NA 00-7711-007-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024131712), received between Dec 17, 2019 and May 14, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Corroded” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K032726, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Corroded; Material Erosion; Corroded; Material Erosion

  INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED, DUE TO A FALL. RESULTING, IN A DISPLACED RIGHT TRANSCERVICAL FEMORAL NECK FRACTURE. SUBSEQUENTLY, THE PATIENT WAS REVISED, DUE TO PAIN AND ELEVATED METAL ION LEVEL. DURING THE REVISION, A BLACKENED LINE WAS NOTED, AROUND THE INTERFACE BETWEEN THE HEAD AND THE PROSTHETIC NECK. CONSISTENT WITH CORROSION OR TRUNNIONOSIS. THE STEM WAS NOTED, TO BE WELL FIXED. THE LINER AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS.

  Patient problems: Fall; High metal ion levels; Metal Related Pathology; Pain; Scar Tissue

  MAUDE report 19313686 ↗
• MalfunctionAug 5, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. DURING THE PROCEDURE A SIZE 7.5 ML TAPER STEM WITH A -3.5MM NECK LENGTH FEMORAL HEAD, AND 44MM BIPOLAR SHELL AND LINER WAS OPENED FOR IMPLANTATION INTO THE PATIENT, AFTER A TRIAL REDUCTION PROCESS APPEARED TO REVEAL SATISFACTORY JOINT LAXITY AND LIMB LENGTH. AFTER ACTUAL IMPLANTATION OF IMPLANTS AND SUBSEQUENT REDUCTION OF THE IMPLANT CONSTRUCT, JOINT LAXITY APPEARED TO BE DISSATISFACTORY. IT WAS UNCLEAR WHETHER THERE WAS ANY SUBSIDENCE OF THE ACTUAL STEM IMPLANT VS THE TRIAL INSTRUMENT. IT WAS ALSO UNCLEAR WHETHER THERE WAS ANY SUBSIDENCE OF THE ACTUAL STEM IMPLANT IN-SITU DURING THE REDUCTION PROCESS. A NEW FEMORAL HEAD, NOW A +0MM NECK LENGTH, WAS USED INSTEAD, AND SURGICAL REDUCTION REVEALED JOINT LAXITY THAT WAS LESS DISSATISFACTORY THAN THE PREVIOUS FEMORAL HEAD. THIS WAS THEN ACCEPTED BY THE SURGEON. THE SURGICAL PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10367422 ↗
• MalfunctionMar 23, 2020Unsealed Device Packaging; Unsealed Device Packaging

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9864946 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 4 DAYS POST IMPLANTATION DUE TO HIP FRACTURE AND PATIENT FALLING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 9480439 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032726, 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