NA 00-7711-011-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024131828), received between Apr 23, 2020 and Apr 1, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 YEAR AND 3 MONTHS POST IMPLANTATION DUE TO PAIN, MILD LIMP DUE TO LEG LENGTH DISCREPANCY, STIFFNESS, POPPING AND GRINDING NOISE THE PATIENT WAS EXPERIENCING WHEN WALKING MAKING MOVING DIFFICULT. DURING THE REVISION, THICK CAPSULE WITH POSTERIOR IMPINGEMENT OF THE TROCHANTER ON THE PELVIS WAS NOTED AS WELL AS A SLIGHTLY RETROVERTED ACETABULAR CUP. TRUNNION FOUND TO BE CLEAN WITHOUT SIGNIFICANT DAMAGE. THE ACETABULAR CUP, FEMORAL HEAD AND POLYETHYLENE LINER WERE REMOVED AND REPLACED. THE SURGEON WAS ABLE TO RESTORE LEG LENGTH. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Joint Impingement; Pain; Unequal Limb Length

  MAUDE report 21744538 ↗
• MalfunctionNov 19, 2020Material Erosion; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Erosion; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND WAS SUBSEQUENTLY REVISED 10 YEARS LATER DUE TO PAIN, INSTABILITY, CUP MIGRATION, LINER WEAR, AND METAL RELATED PATHOLOGY. OPERATIVE NOTE REPORTED INSTABILITY DUE TO POLY LINER DAMAGE WITH VERTICALLY ORIENTATED ACETABULAR COMPONENT. METALLOSIS 2ND TRUNNION WEAR MODULAR NECK AND STEM INTERFACE. TISSUE STAINED WITH GROSS GREYISH BLACK METALLOSIS TYPE TISSUE ON BOTH ACETABULAR AND FEMORAL COMPONENTS. CUP. LINER, HEAD AND STEM REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Metal Related Pathology; No Information; Pain

  MAUDE report 10871178 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 6 WEEKS POST IMPLANTATION DUE TO PAIN, PERIPROSTHETIC FRACTURE AND DIFFICULTY WALKING. DURING THE SURGERY, THE FRACTURE WAS STABILIZED WITH CERCLAGE WIRES AND THE HEAD, LINER AND STEM WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Pain

  MAUDE report 9991289 ↗

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