NA 00-5850-032-14Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
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 00889024195813), received between Aug 15, 2024 and Aug 15, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
- Foreign Body In Patient1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2024Fracture; Fracture
IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY. APPROXIMATELY 5 YEARS POST-OP, THE PATIENT PRESENTED WITH LEFT LATERAL HIP PAIN AND COULD FEEL THE FRACTURED IMPLANTS. THE PATIENT WAS SUBSEQUENTLY REVISED DUE TO 2 IMPLANTED BOLTS FRACTURING. THE THREADED PART OF THE BOLT SCREWS WERE UNABLE TO BE REMOVED AND LEFT IN PLACE AS THERE WERE NO PROPER INSTRUMENTS TO UNSCREW IT FROM THE FEMUR. IN ADDITION, THE SURGEON DID NOT ATTEMPT TO PLACE A NEW WASHER AND BOLT SCREW AS THE CHANCES OF DAMAGING THE BOLT SCREW THREAD WERE HIGH AND IT COULD LEAD TO LOOSENING. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Foreign Body In Patient; Pain
MAUDE report 19990964 ↗
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- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
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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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