OSS™ Orthopedic Salvage System 150510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304240223), received between Nov 16, 2021 and May 12, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (3 reports).

14 other recalls cover devices cleared under the same FDA submission (K002757, K051479); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Fracture; Fracture

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

  Patient problems: Insufficient Information

  MAUDE report 22004847 ↗
• InjuryDec 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION. THREE MONTHS POSTOP, THE PATIENT REPORTED FALLING AND RUPTURED THE MEDIAL RETINACULAR AND UNDERWENT AN IRRIGATION AND DEBRIDEMENT TO ENSURE THERE WAS NO INFECTION AND THE CAPSULE WAS NOT DAMAGED. NO IMPLANTS WERE EXCHANGED. SIX MONTHS AFTER THE FALL, THE PATIENT REPORTS SHE WOKE UP AND HYPEREXTENDED HER KNEE RESULTING IN PAIN AND THE INABILITY TO BEAR WEIGHT. X-RAY IMAGES SHOWED METAL FRAGMENTS FROM THE LOCKING RING AND POLY FRAGMENTS IN THE JOINT. THE PATIENT WAS REVISED ONE MONTH LATER IN WHICH THE METAL AND POLY HINGE MECHANISMS WERE REPLACED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Fall; Hyperextension; Muscle/Tendon Damage; Pain; Subluxation

  MAUDE report 21035688 ↗
• InjuryNov 18, 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.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 12837108 ↗
• InjuryNov 16, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 12820608 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002757, K051479. 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-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-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-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-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-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-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-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-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-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