ORTHOPEDIC SALVAGE SYSTEM (OSS)Recalls & reported problems across all models
Biomet Orthopedics, LLC · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls
- 1
We found 8 models of ORTHOPEDIC SALVAGE SYSTEM (OSS) by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Aug 26, 2020 and Mar 31, 2026 — classified as 40 injuries.
The most frequently reported specific device problem is “Fracture” (21 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ORTHOPEDIC SALVAGE SYSTEM (OSS) recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 21, 2019Terminated
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Z-0526-2020 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported ORTHOPEDIC SALVAGE SYSTEM (OSS) problems
Device problems
- Fracture21
- Adverse Event Without Identified Device or Use Problem14
- Unstable7
- Insufficient Device Problem Information4
- Patient Device Interaction Problem3
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated2
- Naturally Worn2
Patient problems
- Pain18
- Failure of Implant17
- Insufficient Information8
- Ambulation or Postural Difficulties6
- Joint Laxity5
- Scar Tissue4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Bacterial Infection3
ORTHOPEDIC SALVAGE SYSTEM (OSS) models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) CP111827Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Orthopedic Salvage System (OSS) 150493Prosthesis, hip, semi-constrained, metal/polymer, cemented32 reports
- ORTHOPEDIC SALVAGE SYSTEM (OSS) 150478Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- ORTHOPEDIC SALVAGE SYSTEM (OSS) 150477Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ORTHOPEDIC SALVAGE SYSTEM (OSS) 161029PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ORTHOPEDIC SALVAGE SYSTEM (OSS) 161034PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Orthopedic Salvage System (OSS™) CP114831PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Orthopedic Salvage System (OSS™) CP114842PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent ORTHOPEDIC SALVAGE SYSTEM (OSS) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 31, 2026Fracture
No further event information is available at the time of this report.
Patient problems: Joint Laxity; Pain
MAUDE report 24744949 ↗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 9, 2025Fracture; Fracture
IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT COMPLAINED OF PAIN OVER A SPAN OF THE LAST YEAR. THE SURGEON BELIEVED THE EXPANDABLE COMPONENT WAS EXPANDING ON ITS OWN, WITHOUT THE REQUIRED SURGERY TO EXPAND IT. THE PATIENT FELT A POP AND COULD NOT BEAR WEAR. THE PATIENT WAS THEN REVISED APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO A BROKEN ANCHOR PLUG AND THE SPINDLE LOST BONE IN-GROWTH AT THE BONE INTERFACE AND WAS NO LONGER FIXED.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 23010371 ↗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 21036123 ↗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 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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