NA 00-7711-010-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024131781), received between Mar 19, 2020 and Jun 4, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K032726, K161830, K192660); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Failure of Implant; Inadequate Osseointegration; Pain; Radiolucent Lines

  MAUDE report 19459330 ↗
• InjuryDec 29, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY TWELVE YEARS POST-IMPLANTATION DUE TO A DISLOCATION. DURING THE REVISION SURGERY, THE SURGEON NOTICED TRUNION WEAR AND A PSEUDOTUMOR POSSIBLY DUE TO METAL ION RELEASE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; Metal Related Pathology; Osteolysis; Osteopenia/ Osteoporosis

  MAUDE report 18418149 ↗
• InjuryNov 29, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE. A FEW MONTHS LATER, THE PATIENT BEGAN EXPERIENCING PAIN. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 9 MONTHS POST IMPLANTATION, DUE TO THE FEMORAL STEM SUBSIDING WITH NO BONE INGROWTH. THE HIP JOINT WAS ASEPTIC, AND PATIENT DID NOT EXPERIENCE ANY TRAUMA POST OPERATIVE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 18227124 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11605964 ↗
• InjuryApr 1, 2021Corroded; Corroded

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11604299 ↗
• MalfunctionMar 19, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS DEBRIS IN THE STERILE PACKAGING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 9857275 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032726, K161830, K192660. One submission often covers many models, so check the product and lot details in each record.

• Z-1191-2018 · Mar 1, 2018 · Terminated
  Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-0
• Z-1046-2016 · Feb 11, 2016 · Terminated
  M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
• Z-2033-2014 · May 23, 2014 · Terminated
  Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem com