Orthopedic Salvage System (OSS) 150493Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00880304240094), received between Aug 26, 2020 and Jan 15, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Fracture” (19 reports).

16 other recalls cover devices cleared under the same FDA submission (K002757, K052685); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 3 YEARS POST-OP, THE PATIENT SUFFERED A YOKE FRACTURE AND WAS SUBSEQUENTLY REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24080826 ↗
• InjuryJan 13, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 1 YEAR POST-OP, THE PATIENT WAS REVISED DUE TO THE MEDIAL EAR OF THE YOKE FRACTURING OFF. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24054564 ↗
• InjuryNov 14, 2025Unstable; Patient-Device Incompatibility; Patient Device Interaction Problem; Unstable; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS EXCESSIVE HYPEREXTENSION AND INSTABILITY APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. DURING THE REVISION, THE FEMORAL BUSHINGS AND POLYETHYLENE TIBIAL BEARING WERE IDENTIFIED TO HAVE FRACTURED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hyperextension

  MAUDE report 23555789 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO STIFFNESS/ SCAR TISSUE ONE YEAR, EIGHT MONTHS POST INITIAL IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 22983640 ↗
• InjuryAug 7, 2025Fracture; Fracture

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 6 MONTHS POST-OP DUE TO INSTABILITY AND A YOKE FRACTURE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 22745018 ↗
• InjuryJul 15, 2025Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, ON AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO COMPONENT FAILURE. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 22512646 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT IMPLANTATION OF ZIMMER BIOMET DEVICES ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT HAS BEEN INDICATED FOR A POSSIBLE REVISION DUE TO PAIN IN THE TIBIAL REGION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22385124 ↗
• InjuryMar 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE KNEE PROCEDURE. APPROXIMATELY FOUR (4) YEARS POST-IMPLANTATION, THE WINGS OF THE YOKE COMPONENT FRACTURED AND THE PATIENT UNDERWENT REVISION SURGERY. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21658056 ↗
• InjuryFeb 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE SURGERY. APPROXIMATELY 6 MONTHS POST-OP, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A YOKE IMPLANT FRACTURE. BOTH OF THE TABS OF THE IMPLANT HAD SNAPPED OFF. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 21433405 ↗
• InjuryFeb 3, 2025Fracture; Fracture

  NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 21292142 ↗
• InjuryJan 29, 2025Fracture; Unstable; Fracture; Unstable

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 21263749 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS FLEXION CONTRACTURE AND STIFFNESS APPROXIMATELY TWENTY-TWO (22) MONTHS FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint Contracture; Loss of Range of Motion

  MAUDE report 21036082 ↗
• InjuryNov 11, 2024Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE IMPLANT FRACTURE AND INSTABILITY APPROXIMATELY TWENTY-ONE (21) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 20652377 ↗
• InjuryAug 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO FRACTURE OF THE YOKE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20055509 ↗
• InjuryApr 25, 2024Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN, INSTABILITY, AND A CLUNKING SENSATION. DURING THE REVISION IS WAS NOTED THAT THE YOKE HAD BROKEN, DAMAGE TO POLY INSERT, AS WELL AS SCRATCHES NOTED ON COMPONENTS BUT WELL FIXED. NO INTRAOPERATIVE COMPLICATIONS NOTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 19187019 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Adhesion(s); Pain; Scar Tissue

  MAUDE report 18185127 ↗
• InjuryAug 15, 2023Unstable; Patient Device Interaction Problem; Unstable; Patient Device Interaction Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17552874 ↗
• InjuryAug 3, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT PRESENTED WITH LEFT KNEE PAIN AND INSTABILITY APPROXIMATELY FIVE YEARS POSTOP AND UNDERWENT A REVISION SURGERY. THE BEARING AND BUSHING KIT WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Pain

  MAUDE report 17452214 ↗
• InjuryApr 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16713773 ↗
• InjuryMar 22, 2023Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT KNEE REVISION APPROXIMATELY 2.5 MONTHS POST IMPLANTATION DUE TO IMPLANT FRACTURE. THE FLANGES ON THE YOKE BROKE. ALL DEVICES WERE EXPLANTED A NEW OSS SYSTEM WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain; Scar Tissue

  MAUDE report 16590457 ↗
• InjuryMar 21, 2023Fracture; Unstable; Noise, Audible; Fracture; Unstable; Noise, Audible

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 16582798 ↗
• InjuryJan 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 MONTHS LATER DUE TO AN IMPLANT FRACTURING. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16151722 ↗
• InjuryNov 4, 2022Fracture; Unstable; Device Dislodged or Dislocated; Fracture; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE EIGHT MONTHS POST IMPLANTATION DUE TO PAIN AND TIBIAL DISLOCATION IN KNEE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Joint Dislocation; Pain

  MAUDE report 15734438 ↗
• InjuryJul 20, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS IMPLANT BREAKAGE POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Failure of Implant; Hyperextension; Pain

  MAUDE report 15064299 ↗
• InjuryFeb 17, 2022Fracture; Patient Device Interaction Problem; Fracture; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE FRACTURE OF THE YOKE, DAMAGE TO THE TIBIAL BEARING, PAIN AND DIFFICULTY AMBULATING APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 13548447 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002757, K052685. One submission often covers many models, so check the product and lot details in each record.

• Z-0623-2021 · Nov 25, 2020 · Terminated
  OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
• Z-2147-2020 · Apr 17, 2020 · Terminated
  Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
• Z-0590-2019 · Oct 10, 2018 · Terminated
  Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
• Z-0303-2018 · Jun 5, 2017 · Terminated
  OSS CEMENTED IM STEM 12X150, model # 150366
• Z-0417-2012 · Nov 1, 2011 · Terminated
  OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cement
• Z-1531-2009 · May 19, 2009 · Terminated
  Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472125. A non-powered, orthopedic manual surgical
• Z-1530-2009 · May 19, 2009 · Terminated
  Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472124. A non-powered, orthopedic manual surgic
• Z-1526-2009 · May 19, 2009 · Terminated
  Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472086. A non-powered, orthopedic manual surgical instru
• Z-1529-2009 · May 19, 2009 · Terminated
  Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472089. A non-powered, orthopedic manual surgical instr
• Z-1527-2009 · May 19, 2009 · Terminated
  Biomet OSS FINN Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472087. A non-powered, orthopedic manual surgical instrum
• Z-1528-2009 · May 19, 2009 · Terminated
  Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472088. A non-powered, orthopedic manual surgical inst
• Z-1881-2008 · May 15, 2008 · Terminated
  Biomet OSS Interlok IM Stem w/Screw, straight collar, 15 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150492. Orthopedic implant intended as part
• Z-1879-2008 · May 15, 2008 · Terminated
  Biomet OSS Interlok IM Stem w/Screw, straight collar, 11 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150490. Orthopedic implant intended as part
• Z-1880-2008 · May 15, 2008 · Terminated
  Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150491. Orthopedic implant intended as part
• Z-2213-2008 · Nov 7, 2007 · Terminated
  OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used

…and 1 more.