Implant fracture of the Regenerex® modular metal tibial component: A report of three cases

• Published in: The knee 2019-10, Vol.26 (5), p.1143-1151
• Main Authors: Rytter, Søren, Madsen, Frank, Jepsen, Claus Fink, Stilling, Maiken
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Arthritis; Arthroplasty; Arthroplasty, Replacement, Knee - adverse effects; Bone density; Bone implants; Case reports; Cement; Chloride; Double-Blind Method; Failure; Female; Fracture; Fractures; Humans; Knee; Knee Prosthesis - adverse effects; Male; Metals; Middle Aged; Patients; Pilot Projects; Prospective Studies; Prosthesis Design; Regenerex; Reoperation; Sodium; Surgeons; Surgery; Tibia - diagnostic imaging; Tibia - injuries; Tibia - surgery; Tibial Fractures - diagnosis; Tibial Fractures - etiology; Tibial Fractures - surgery; Titanium; Transplants & implants; Young Adult
• ISSN: 0968-0160; 1873-5800
• DOI: 10.1016/j.knee.2019.06.009

Implant fractures are a very rare complication in primary total knee replacement (TKR) surgery and with modern implant designs and improved metals these events have nearly been eliminated. In this case series we report three cases of tibial metal baseplate fractures in uncemented Regenerex® TKR. Cases originated from a prospective case series of 80 patients operated between 2013 and 2016. Five patients were pilot cases and 75 were participants in a prospective randomized double-blinded clinical trial that evaluated different adjuvant bone anti-resorptive medical therapies. All patients were treated with an uncemented press-fit Regenerex® Porous Titanium Construct tibial tray and matching cemented (Refobacin Bone Cement R) patella and femoral components (hybrid implant). We report three cases of medial side metal baseplate fractures of a modular finned tibial stem. All three baseplate fractures were in male patients. Confirmed failure of the implant occurred after 10, 12 and 23 months, in situ, with a mean follow-up of 15 months (range 10-23). Based on the current case series we cannot make any causal inferences. Failures may represent a multifactorial process with a cascade of events with implant failure as the result. However, like in most other case reports of metal failures in the literature, the implant fractures in this report were located on the medial side of the tibial component in male patients.