NA 00-7711-009-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024131750), received between Jul 1, 2020 and Aug 6, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Erosion” (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.

• MalfunctionAug 6, 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 19917470 ↗
• InjuryFeb 27, 2024Material Erosion; Naturally Worn; Insufficient Device Problem Information; Material Erosion; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND ELEVATED CHROMIUM LEVELS. DURING THE REVISION, NECROTIC AND AVASCULAR TISSUE CONSISTENT WITH TRUNNIONOSIS WAS DEBRIDED FROM THE JOINT SPACE. THE STEM WAS CLEARED OF BLACK METAL DEBRIS, AND A NEW HEAD AND LINER WERE PLACED WHILE THE INITIAL STEM AND SHELL REMAINED INTACT. OVER TIME THE PATIENT¿S SERUM METAL ION LEVELS RETURNED TO NORMAL LEVELS.

  Patient problems: Failure of Implant; High metal ion levels; Insufficient Information; Muscle/Tendon Damage; Necrosis; Osteolysis; Pain

  MAUDE report 18787171 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A CORTISONE INJECTION APPROXIMATELY THREE MONTHS POST IMPLANTATION, DUE TO RIGHT HIP IMPINGEMENT, TENDONITIS, AND RIGHT HIP PAIN APPROXIMATELY. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Impingement; Pain

  MAUDE report 17954412 ↗
• InjuryDec 12, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE AGENT DISASSEMBLED THE CERAMIC HEAD AND ASSEMBLED IT INTO THE BIPOLAR HEAD IN THE CORRECT WAY. AFTER THE DOCTOR IMPLANTED THE PRODUCT, HE FOUND THAT THE FEMORAL HEAD COULD NOT BE FIXED ON STEM STABLY AND FORMED A TAPER LOCKING. THERE WAS A 70 MINUTE DELAY IN THE SURGERY. PROLONGED ANESTHESIA TIME AND INCREASED BLOOD TRANSFUSION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15961921 ↗
• InjuryOct 13, 2021Corroded; Material Erosion; Corroded; Material Erosion

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

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 12629114 ↗
• MalfunctionJul 1, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED DURING INSPECTION AT THE (B)(6) WAREHOUSE THAT THE PACKAGE WAS DAMAGED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 10218227 ↗

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