NA 00-7711-009-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024131743), received between Apr 1, 2021 and Apr 7, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Corroded” (3 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.

• InjuryApr 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN IN THE THIGH BONE MIDWAY DOWN THE FEMUR. THE DEVICES REMAIN IMPLANTED AND THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 21785995 ↗
• MalfunctionSep 30, 2024Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334856 ↗
• InjurySep 29, 2021Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem; Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT THAT THEY UNDERWENT A LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, UNDERWENT A REVISION PROCEDURE SIX (6) YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Adhesion(s); Failure of Implant; Insufficient Information; Metal Related Pathology; Osteolysis; Scar Tissue

  MAUDE report 12547272 ↗
• InjuryAug 2, 2021Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem; Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT LEFT A LEFT HIP REVISION SURGERY 11 YEARS POST IMPLANTATION DUE TO ELEVATED METAL ION LEVELS. DURING THE REVISION THE SURGEON NOTED CORROSION AND PSUEDOCAPSULE WITH CAPSULOTOMY PERFORMED. THE HEAD AND LINER WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 12258864 ↗
• InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Metal Related Pathology; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11607911 ↗
• InjuryApr 1, 2021Corroded; Material Erosion; Corroded; Material Erosion

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

  Patient problems: Metal Related Pathology; Necrosis; Pain; Swelling/ Edema

  MAUDE report 11602974 ↗

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