NexGen® 5987-71Recalls & 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
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024219595), received between Sep 10, 2019 and May 22, 2025 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Fracture” (14 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. 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
- Fracture14
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Code Available1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Fracture; Fracture
IT WAS REPORTED THAT AN ALLEN WRENCH FRACTURED AFTER SECURING THE SET SCREW DOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069234 ↗MalfunctionAug 12, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19960197 ↗MalfunctionMay 15, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19324950 ↗MalfunctionApr 3, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16664136 ↗MalfunctionJan 31, 2023Fracture; Fracture
IT WAS REPORTED THAT AN INSTRUMENT FELL AND FRACTURED DURING VERIFICATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16272877 ↗MalfunctionDec 20, 2022Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16017863 ↗MalfunctionMar 8, 2022Fracture; Fracture
IT WAS REPORTED THAT THE SURGERY COORDINATOR DROPPED THE DRIVER AND IT THE CART, SNAPPING INTO TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13693264 ↗MalfunctionDec 20, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13046280 ↗MalfunctionDec 9, 2021Fracture; Fracture
IT WAS REPORTED THE INSTRUMENT WAS FOUND TO BE FRACTURED IN HALF DURING THE INSPECTION OF THE LOANER KIT IN THE WAREHOUSE. NO SURGERY OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12971335 ↗MalfunctionNov 22, 2021Fracture; Fracture
SEE H10 NARRATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12857510 ↗MalfunctionNov 10, 2021Fracture; Fracture
IT WAS REPORTED THAT AT THE DISTRIBUTORSHIP THE DEVICE WAS DISCOVERED FRACTURED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12787217 ↗MalfunctionSep 9, 2021Fracture; Fracture
IT WAS REPORTED THAT THE PRODUCT BROKE WHEN THREADING THE SCREWS THAT FIX THE STEM AS SECURITY MEASURE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12448071 ↗MalfunctionAug 19, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12342484 ↗MalfunctionSep 10, 2019Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 8980914 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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