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Purpose: Computer-assisted arthroplasty supports the surgeons in planning, simulating, and performing the replacement procedure, using robotic or navigation technologies. However, the safety of the technology has not been widely ascertained. Food and Drug Administration (FDA) database was interrogated about software-related recalls in computer-assisted arthroplasty, aiming to assess: (1) the incidence, (2) the root causes, and (3) the actions taken due to recalls., Methods: The Medical Device Recalls database was investigated about software-related recalls in computer-assisted hip and knee arthroplasty surgery, between 2017 and 2022. The incidence of the software-related recalls, the root causes according to FDA and manufacturers, and the corrective actions taken by firms were determined., Results: Eighteen recall numbers could be identified (1.6%), corresponding to 11 recall events. A total of 4634 units were involved. The FDA determined root causes were: software design (66.6%), design change (22.2%), manufacturing deployment (1, 5.6%), and design manufacturing process (5.6%). Among the manufacturers' reasons for recalls, a specific error was declared in 16 cases (88.9%). In seven cases (43.8%), a coding error about lower limb alignment assessment was identified. Seventeen software-related recalls (94.4%) were classified as class 2; only one case was class 3 (5.6%). Return of the device was the main action taken by firms (8, 44.4%), followed by software update (7, 38.9%)., Conclusion: Software-related recalls in computer-assisted hip and knee arthroplasty were quite uncommon among all the recalls, deemed non-life threatening and usually due to software design errors. The main actions taken by manufacturers were the return of the device or the software update., (© 2023. The Author(s) under exclusive licence to SICOT aisbl.)

Introduction: Total hip arthroplasty (THA) is the standard procedure for post-traumatic osteoarthritis (OA) of the hip after acetabular fracture. However, it is not as simple as a primary THA, challenging the surgeon with anatomical deformity and intra and postoperative complications. In the current literature, there is a lack of studies reporting long-term results. May ceramic-on-ceramic (CoC) bearings provide good clinical and radiological outcomes at a long-term follow-up in patients undergoing THA following acetabular fracture?, Materials and Methods: We retrospectively analyzed 68 patients (mean age 47 years [range 22-75)] who underwent cementless modular neck stem THA, all implants CoC bearings (50 previously operatively treated and 18 non-operatively treated) after a specific CT study protocol at our Institute since 2000-2008. Clinical outcomes, prosthetic components' osseointegration, survival rate, and reasons for revision were analyzed. Minimum clinical and radiological follow-up was 10 years., Results: HHS improved significantly after surgery from 37.6 ± 14.1 to 88.4 ± 11.6. 8 revision surgeries were performed, none for infection: we reported 2 stem aseptic loosening, 2 periprosthetic femoral fractures and 4 modular neck fractures. One implant noise (third-generation ceramic coupling) was described. Cup osseointegration was present (according to Moore the presence of at least 3 radiological criteria defines an effective osseointegration) in 67 patients (98.5%). After a 10 years follow-up, survival rate resulted 88.4%, sensibly higher than most of results reported in the current literature., Conclusion: The high survival rate may be related to CoC: no osteolysis and no infections were reported. Also acetabular cup loosening incidence was sensibly lower (1.47%) among loosening rate described by other authors. Clinical and radiological outcomes were decent, probably due to modular prosthesis design. Modular necks are a solution which can help achieving a proper functional reconstruction of the hip (offset, center of rotation), but should be avoided in young and overweight patients because of the high risk of fracture. CoC bearings in THAs in post-traumatic OA after acetabular fracture showed good results despite the fact that specific ceramic-related issues have to be considered.

Purpose: Highly porous cups were developed to improve osseointegration and reduce the rate of aseptic loosening. Highly porous titanium cups could mix the reliability of titanium metal with an enhanced porosity, improving the bony ingrowth. The aim of this report was to assess the survival rates and reasons for revision of a highly porous titanium cup, Fixa Ti-Por (Adler Ortho, Milan, Italy), fabricated using an additive manufacturing., Methods: The Registry of Prosthetic Orthopedic Implants (RIPO), the Emilia-Romagna region arthroplasty registry, was enquired about cementless cups, implanted since July 2007. Ti-Por cups were compared to all the other cementless sockets, acting as a control group. The survival rates and reasons for revision were evaluated and compared. Comparisons with the same articular couplings were also provided., Results: When all the articular couplings were included, Ti-Por performed better, achieving a statistically higher survival rate than the control group (98.7% vs 97.9%) and a statistically lower incidence of cup aseptic loosening. In case of ceramic on polyethylene couplings, Ti-Por achieved similar survival rate: cup aseptic loosening in Ti-Por group was 0.2%, whereas the control group rated 0.4%. In ceramic-on-ceramic implants, the survival rate was similar in the two groups, Ti-Por achieving a cup aseptic loosening rate of 0.1% (vs 0.14% in the control group)., Conclusion: Highly porous titanium cups showed trustworthy results at eight years, reducing the rate of aseptic loosening. Longer follow-ups, ion analyses, and pre-clinical in vivo studies would be helpful to better define the reliability of these devices and their advantages.