NA 00-7711-010-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024131811), received between Jul 2, 2021 and May 26, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2022Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth; Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INCREASING PAIN, ELEVATED METAL IONS, AND A PERIPROSTHETIC GREATER TROCHANTER FRACTURE APPROXIMATELY 10 YEARS POST IMPLANTATION. THE PATIENT HAD TO USE AN AMBULATION AID DUE TO THE PAIN. DURING THE REVISION, METALLOSIS, FLUID, LOOSENING OF ACETABULAR AND FEMORAL COMPONENTS, OSTEOLYSIS, AND SMALL ANTERIOR PSEUDOTUMOR WERE NOTED. ALL IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT. THE FRACTURE WAS REDUCED AND STABILIZED WITH CABLES. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Metal Related Pathology; Osteolysis; Pain

  MAUDE report 14515099 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION SURGERY 3 MONTHS¿ POST IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE. 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 12108852 ↗

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