NexGen® 5977-20Recalls & reported problems
Zimmer, Inc. · Class 1
All models of NexGen (198)
Data updated Oct 16, 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 00889024216266), received between Apr 19, 2022 and Apr 19, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2022Fracture; Fracture
IT WAS REPORTED THE PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY. DURING REVIEW OF THE POST-OPERATIVE X-RAY, A SPHERICAL FOREIGN BODY WAS DETECTED. THE FOREIGN BODY WAS IMMEDIATELY REMOVED. THE FOREIGN PIECE WAS FROM THE ARTICULAR SURFACE INSERTER. THE SURGERY WAS DELAYED 35 MINUTES TO REMOVE THE FOREIGN PIECE. THE PATIENT DID NOT NEED TO BE RE-ANESTHETIZED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 14151754 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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