NA 00-7804-015-20Recalls & reported problems
Zimmer, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024133945), received between Feb 19, 2021 and Feb 7, 2025 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Fracture” (11 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture11
- Difficult or Delayed Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2025Fracture; Fracture
NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21333429 ↗MalfunctionOct 17, 2024Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469799 ↗MalfunctionApr 12, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 19095013 ↗MalfunctionMar 15, 2024Fracture; Fracture
IT WAS REPORTED THAT THE INSERTER TIP WAS FRACTURED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18911486 ↗MalfunctionNov 15, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE SHELL INSERTER TIP BROKE AND REMAINED IN THE SHELL. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE AND NO BROKEN PIECES WERE LEFT IN THE PATIENT. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18141418 ↗MalfunctionAug 4, 2023Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE INSERTER FRACTURED DURING IMPACTION OF THE IMPLANT. NO PIECES FELL IN THE PATIENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17457828 ↗MalfunctionJul 7, 2022Fracture; Fracture
IT WAS REPORTED THE CUP INSERTER FRACTURED AT SCREW IN WHILE IMPACTING CUP TWICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14947091 ↗MalfunctionJul 7, 2022Fracture; Fracture
IT WAS REPORTED THE CUP INSERTER FRACTURED AT SCREW IN WHILE IMPACTING CUP TWICE. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14947063 ↗MalfunctionJun 30, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A HIP SURGERY, THE THREADS ON THE INSTRUMENT FRACTURED. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14872699 ↗MalfunctionJun 15, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE INSTRUMENT FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14700364 ↗MalfunctionJun 18, 2021Fracture; Fracture
UPON REASSESSMENT OF THE REPORTED EVENT, THIS REPORT SHOULD BE VOIDED AS IT WAS DETERMINED TO BE A DUPLICATE OF MFR NUMBER 0001822565 -2021-00180.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12024259 ↗MalfunctionFeb 19, 2021Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THE SURGEON TRIED TO IMPLANT THE SHELL INTO THE PATIENT. HE ACHIEVED GOOD STABILITY WITH THE IMPLANT. WHEN WE TRIED TO REMOVE THE ACETABULAR SHELL INSERTER, THE INSERTER APPEARED TO BE STUCK ON. WE USED MECHANICAL ADVANTAGE TO TRY TO DISLODGE THE SHELL BUT IT DID NOT WORK. IN THE END THE SHELL NEEDED TO BE REMOVED AND A NEW SHELL WAS USED. THE NEW SHELL WENT IN WITHOUT A CHALLENGE WHICH LED US TO THE CONCLUSION THAT POTENTIALLY THE SHELL WAS FAULTY OR SIMPLY CROSS THREADED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11348221 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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