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NA 00-7711-012-20Recalls & reported problems

Zimmer, Inc. · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024131880), received between Dec 8, 2020 and Jan 18, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Device problems

  • Device Dislodged or Dislocated1
  • Loosening of Implant Not Related to Bone-Ingrowth1
  • Material Erosion1
  • Migration1

Patient problems

  • Bone Fracture(s)1
  • Joint Dislocation1
  • Muscle/Tendon Damage1
  • No Information1
  • Pain1
  • Unequal Limb Length1
  • Unspecified Tissue Injury1

Recent adverse event reports

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

  • InjuryJan 18, 2023Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HEMIARTHROPLASTY THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY A WEEK LATER DUE TO DISLOCATION AND A FAILED ATTEMPT OF A CLOSED REDUCTION. DURING THE PROCEDURE IT WAS NOTED THAT THE STEM WAS ROTATIONALLY UNSTABLE AND WAS REMOVED BY HAND, WHICH WAS CEMENTED IN AND SHOULD NOT HAVE BEEN THAT EASY TO REMOVE. ALL COMPONENTS WERE EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Joint Dislocation; Muscle/Tendon Damage

    MAUDE report 16193862 ↗
  • InjuryApr 26, 2021Migration; Migration

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

    Patient problems: Bone Fracture(s); Pain; Unequal Limb Length; Unspecified Tissue Injury

    MAUDE report 11724114 ↗
  • InjuryDec 8, 2020Material Erosion; Material Erosion

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

    Patient problems: No Information

    MAUDE report 10968550 ↗

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

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

Sources and updates

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