OSS™ Orthopedic Salvage System CP113462Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of OSS Orthopedic Salvage System (76)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304840416), received between Jul 2, 2025 and Jul 2, 2025 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K083827); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 22385138 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083827. One submission often covers many models, so check the product and lot details in each record.
- Z-1114-2017 · Dec 16, 2016 · TerminatedOrthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- ELEOS™ THSMWRS01MOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER190 reports
- "UNITED" USTAR II Hip System 1115-1413United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls3 reports
- "UNITED" USTAR II Hip System 1115-1213United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1417United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1217United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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