NexGen® 5987-89Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024219762), received between Dec 9, 2021 and Sep 1, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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
- Fracture7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551978 ↗MalfunctionJul 7, 2025Fracture; Fracture
IT WAS FURTHER REPORTED THE DEVICE FRACTURED AT THE YIELD POINT. THE SURGEON NOTED THE SCREWDRIVER TIP SEEMED STRIPPED AND NOT IN HEX SHAPE. THE FRACTURED TIP WAS REMOVED ALONG WITH THE SCREW USING A SCREW SET FROM THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22420160 ↗MalfunctionAug 15, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19991009 ↗MalfunctionFeb 22, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16422159 ↗MalfunctionOct 25, 2022Fracture; Fracture
IT WAS REPORTED THAT A SCREWDRIVER FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15666068 ↗MalfunctionDec 27, 2021Fracture; Fracture
IT WAS REPORTED THAT ONE OF THE DISTAL TELESCOPING ROD SCREWS JAMMED. THE OPERATING ROOM NURSE TRIED TO UNSCREW IT WITH THE AUGMENT SCREWDRIVER. THE TIP OF THE SCREWDRIVER BROKE OFF IN THE RECESS OF THE SCREW. THEY THEN OPENED ANOTHER SET WITH THE AUGMENT SCREWDRIVER AND DISTAL TELESCOPING ROD TO CONTINUE THE SURGERY. THE SURGERY WAS DELAYED BY 3-5 MINUTES. THERE WAS NO OTHER CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13087774 ↗MalfunctionDec 9, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12969420 ↗
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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