OSS™ Orthopedic Salvage System 150464Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304239852), received between Dec 21, 2020 and Jun 13, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

14 other recalls cover devices cleared under the same FDA submission (K002757, K123501); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN EIGHTY-YEAR-OLD PATIENT WITH A SIGNIFICANT CARDIAC HISTORY HAD A RIGHT TOTAL HIP ARTHROPLASTY WITH COMPETITOR PRODUCT AND, UNDERWENT A REVISION DUE TO FEMORAL LOOSENING AND SIGNIFICANT BONE LOSS. DURING THE PROCEDURE THE PATIENT HAD A TOTAL BLOOD LOSS OF 600ML OF BLOOD LOSS AND RECEIVED TWO UNITS OF RBCS. THE ACETABULAR SYSTEM WAS RETAINED, AND THE STEM, HEAD, AND LINER WERE REVISED WITHOUT FURTHER COMPLICATION. THE PATIENT DISPLAYED WORSENING DYSARTHRIA AND AROUND A CODE STROKE WAS CALLED. A CT AND MRI WERE PERFORMED, AND A CEREBELLAR STROKE WAS CONFIRMED. THE PATIENT REMAINED NPO UNTIL A SWALLOW STUDY WAS PERFORMED. DURING THE SWALLOW STUDY, THE PATIENT EXPERIENCED AN EPISODE OF COUGHING AND BECAME UNRESPONSIVE AND WAS FOUND IN CARDIAC ARREST. THE PATIENT UNDERWENT THREE ROUNDS OF CPR AND INTUBATED AND ROSC WAS ACHIEVED. THE PATIENT WAS TRANSFERRED TO MICU AND, THE MRI DISPLAYED A SHOWER OF EMBOLIC STROKES. NEUROLOGY NOTED THAT THE PATIENT WAS OFF SEDATION, MAINTAINED VENTILATION, AND WAS ABLE TO FOLLOW COMMANDS. THE PATIENT WAS DIAGNOSED WITH ASPIRATION PNEUMONIA AND AFTER WEANING OFF THE VENTILATOR, THE PATIENT EXPIRED. ALL IMPLANTS REMAINED IN PLACE AND NO F

  Patient problems: Aspiration/Inhalation; Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Pneumonia; Stroke/CVA

  MAUDE report 19528633 ↗
• MalfunctionDec 21, 2020Mechanical Jam; Mechanical Jam

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

  Patient problems: No Information

  MAUDE report 11046348 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002757, K123501. 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-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-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-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-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-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