NA 5842-13-02Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
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 00889024193758), received between Apr 9, 2024 and Apr 9, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K033363); 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
- Insufficient Device Problem Information1
Patient problems
- Arthritis1
- Metal Related Pathology1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO METALLOSIS. ON REVISION, THE MEDIAL COMPARTMENT WAS FELT TO BE OVER-STUFFED AND WITH INADEQUATE TIBIAL SLOPE. THE PATIENT HAD BEEN DROPPING OFF THE BACK OF THE TIBIAL COMPONENT AND ERODED THE POLY. SOME METALLOSIS WAS DISCOVERED. THE IMPLANTS WERE OTHERWISE WELL FIXED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Arthritis; Metal Related Pathology
MAUDE report 19073733 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K033363. One submission often covers many models, so check the product and lot details in each record.
- Z-1054-2018 · Nov 29, 2017 · TerminatedZUK PRC FEM SZB RMED/LLAT ZUK PRC FEM SZC LMED/RLAT ZUK PRC FEM SZC RMED/LLAT NGU PRC FEM SZD LMED/RLAT ZUK PRC FEM SZD RMED/LLAT ZUK PRC FEM SZE LMED/RLAT ZUK PRC FEM SZF RMED/LLA
- Z-0836-2016 · Jan 11, 2016 · TerminatedZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful an
- Z-0076-2014 · Aug 30, 2013 · TerminatedZimmer Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 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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