NA 00-7711-012-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024131866), received between Sep 26, 2022 and Dec 11, 2023 — classified as 2 injuries.

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

• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY SEVEN YEARS POST IMPLANTATION DUE TO RECURRING DISLOCATIONS. DURING THE PROCEDURE, THE SURGEON ENCOUNTERED A LARGE AMOUNT OF EDEMA IN THE SUBCUTANEOUS TISSUES, OSTEOLYSIS WITH OSTEOLYTIC TISSUE, AND INSTABILITY. THE SURGEON ALSO FOUND HETEROTOPIC BONE OF THE ACETABULUM AND FEMUR, LARGE PSEUDOTUMOR WITH SOFT TISSUE NECROSIS, TRUNNIONOSIS, POLY WEAR, AND METALLOSIS THROUGHOUT ALL THE TISSUES. ALL THE IMPLANTS, EXCEPT FOR THE STEM, WERE REVISED WITHOUT FURTHER COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Osteolysis; Swelling/ Edema

  MAUDE report 18303884 ↗
• InjurySep 26, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY 4 YEARS POST-IMPLANTATION. THE PATIENT HAS EXPERIENCED PAIN AND DISCOMFORT IN RELATION TO THE IMPLANTATION OF THE PRODUCT. PRIOR TO THE REVISION SURGERY, THE PATIENT UNDERWENT DIAGNOSTIC TESTING OF HER BLOOD CHEMISTRY; ANALYSIS CONDUCTED INDICATED THAT THE PATIENT HAD SUSTAINED HIGH LEVELS OF CHROMIUM AND COBALT CONCENTRATE. AS A RESULT, THE PATIENT HAS SUSTAINED AND WILL SUSTAIN SERIOUS INJURIES TO THEIR BODY, THE PARTICULARS OF WHICH INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING: METALLOSIS, TISSUE DEHISCENCE, TISSUE NECROSIS, BONE NECROSIS, HYPERTROPHIC SCARRING, ANTALGIA, LUMBAR STRAIN, CHRONIC PAIN AND SEVERE EMOTIONAL AND/OR PSYCHOLOGICAL DISTRESS RELATING TO THE PAIN AND SUFFERING ASSOCIATED WITH THE DEFECTIVE PRODUCT. NO ADDITIONAL INFORMATION.

  Patient problems: Metal Related Pathology; Necrosis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15485536 ↗

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