NA 00-7711-004-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024131613), received between May 6, 2021 and Sep 14, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K060040, 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.

Recalls naming this device

1. Jul 26, 2023Class IIOpen, Classified

   The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

   Z-2519-2023 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

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.

• MalfunctionSep 14, 2026Tear, Rip or Hole in Device Packaging

  It was reported that the implant broke through the sterile packaging. There was no patient involvement. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50751894 ↗
• MalfunctionApr 17, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE FEMORAL STEM WAS IMPROPERLY PACKAGED AND THAT THE STERILE PACKAGING WAS DAMAGED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860566 ↗
• InjuryDec 20, 2023Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem; Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Joint Laxity; Loss of Range of Motion; Pain; Tendinopathy; Unequal Limb Length

  MAUDE report 18365384 ↗
• MalfunctionMay 6, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787751 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060040, K192660. One submission often covers many models, so check the product and lot details in each record.

• Z-2361-2018 · May 30, 2018 · Terminated
  Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
• Z-1192-2018 · Mar 1, 2018 · Terminated
  Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10