NA 00-7711-005-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024131620), received between Nov 23, 2021 and Apr 20, 2026 — classified as 1 injury, 4 malfunctions.

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

3 other recalls cover devices cleared under the same FDA submission (K032726, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE IMPLANT WAS OPENED AND THE STEM HAD POKED THROUGH BOTH PLASTIC BARRIERS. NO PATIENT INVOLVEMENT OR IMPACT REPORTED. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925045 ↗
• InjuryFeb 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY ON. SUBSEQUENTLY, DEVELOPED PAIN AND RADIOGRAPHIC IMAGING DISPLAYED EVIDENCE OF FEMORAL PROSTHETIC LOOSENING, AND UNDERWENT A REVISION APPROXIMATELY 3 YEARS POST-IMPLANTATION. DURING THE PROCEDURE, THE CUP WAS WELL FIXED AND SURGEON HAD PLANNED TO RETAIN THE LINER. DURING REDUCTION, THE HIGH WALL LINER WAS BENT AND WAS EXCHANGED TO A NEUTRAL LINER. THE HEAD AND STEM WERE REVISED WITH COMPETITOR PRODUCTS, THE LINER WAS REVISED WITH A ZB NEURAL LINER, AND THE ZB CUP AND SCREW WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24387624 ↗
• MalfunctionAug 3, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHEN THE OUTER BOX WAS OPENED, THE DISTAL TIP OF THE STEM WAS FOUND PROTRUDING OUT OF THE OUTER PLASTIC PACKAGING RESULTING IN A WEAR MAKE ON THE INNER SIDE OF THE CARDBOARD BOX. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455900 ↗
• MalfunctionOct 14, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE BARRIER OF THE IMPLANT CONTAINER WAS PUNCTURED. A NEW DEVICE WAS USED TO COMPLETE THE SURGERY. EVENT WAS FOUND IN THE OPERATING ROOM HOWEVER, THERE WAS NO DIRECT PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15603831 ↗
• MalfunctionNov 23, 2021Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862201 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032726, 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