Zimmer® Universal Power System 89850740000Recalls & reported problems
Zimmer Surgical SA · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024354593), received between Dec 8, 2022 and Oct 9, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Shut Off” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Shut Off2
- Physical Resistance/Sticking2
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2024Failure to Shut Off; Physical Resistance/Sticking; Failure to Shut Off; Physical Resistance/Sticking
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20406098 ↗MalfunctionAug 22, 2024Failure to Shut Off; Physical Resistance/Sticking; Failure to Shut Off; Physical Resistance/Sticking
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS MEDWATCH # (B)(4) IS A DUPLICATE OF MEDWATCH # (B)(4) WHICH IS REPORTED UNDER MFR 0008031000-2024-00163. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20036665 ↗InjuryDec 8, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A DEFECT WAS DISCOVERED WHEN THE MACHINE WAS CHECKED AT THE BEGINNING OF THE OPERATION. DESPITE THE REPLACEMENT OF THE BATTERY AND THE BATTERY HOUSING, THE MACHINE DID NOT WORK AND SINCE NO MORE MACHINES WERE AVAILABLE THAT DAY, THE OPERATION HAD TO BE CANCELLED. THE PATIENT WAS ALREADY UNDER ANESTHESIA AND HAD TO BE DISCHARGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15938134 ↗
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- NA 72202530Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES53 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.