OSS™ Orthopedic Salvage System 150477Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00880304817708), received between Mar 4, 2021 and Sep 5, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

14 other recalls cover devices cleared under the same FDA submission (K002757); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 22983704 ↗
• 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 22385146 ↗
• MalfunctionDec 19, 2023Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354902 ↗
• 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 18185021 ↗
• InjuryAug 16, 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 17555745 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE DOCTOR REPAIRED A TORN TENDON AND EXCHANGED THE POLY, TIBIAL AND FEMORAL BUSHINGS, AXLE, YOKE AND LOCKING PIN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 12780680 ↗
• InjuryApr 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THE LOCKING RING FRACTURE IS WHAT CAUSED THE YOKE TO DISASSOCIATE FROM THE TIBIAL TRAY. THEREFORE, THE LOCKING RING IS THE ONLY REPORTABLE ITEM. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11739419 ↗
• InjuryApr 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Damage to Ligament(s); Impaired Healing; Pain

  MAUDE report 11716288 ↗
• InjuryApr 1, 2021Adverse 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. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Necrosis; Sepsis; Wound Dehiscence

  MAUDE report 11604391 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT REVISION PROCEDURE APPROXIMATELY 3 MONTHS AGO DUE TO IMPLANT FRACTURE. ABOUT ONE MONTH LATER, THE PATIENT PRESENTED TO THE ER WITH SIGNS OF INFECTION AND A REVISION OF BOTH FEMORAL AND TIBIAL COMPONENTS FROM THE RIGHT DISTAL FEMUR TOOK PLACE WITH AN I & D AND PLACEMENT OF WOUND VAC DUE TO INFECTION. THE FOLLOWING DAY THE PATIENT RETURNED TO THE OR FOR A PLANNED DEBRIDEMENT TO MINIMIZE BACTERIAL BURDEN. THE PATIENT THEN RETURNED TO THE OR TWO DAYS LATER FOR THE 2ND STAGE OF REVISION WHICH INCLUDED REMOVAL OF ANTIBIOTIC DELIVERY DEVICE WITH REIMPLANTATION AND REVISION OF TIBIAL COMPONENT, RIGHT DISTAL REMOVAL REPLACEMENT WITH HINGED COMPONENT MECHANISM AS WELL AS EXCISIONAL DEBRIDEMENT OF MUSCLE, SUBCUTANEOUS TISSUE. THE PATIENT REQUIRED PLASTIC SURGEON FOR THE COMPLEXITY OF THE WOUND. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Insufficient Information; Necrosis; Sepsis; Wound Dehiscence

  MAUDE report 11423284 ↗
• InjuryMar 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE UNDER THIS FILE, BUT REPORTED UNDER CMP-0674857. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Insufficient Information

  MAUDE report 11415358 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002757. 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-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-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-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-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-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