NA 71302808Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010194145), received between Jan 4, 2018 and Mar 14, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K211176, K963509); 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 16, 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.

• InjuryMar 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED WITH A ROUTINE WASH-OUT AND COMPONENT EXCHANGE DUE TO INFECTION. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11478938 ↗
• InjuryMar 31, 2020Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FEMORAL NECK FRACTURE. STEM AND FEMORAL HEAD WERE EXPLANTED AND REPLACED FOR ZIMMER BIOMET STEM.

  Patient problems: Injury

  MAUDE report 9902686 ↗
• InjuryMar 31, 2020Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FEMORAL NECK FRACTURE. STEM AND FEMORAL HEAD WERE EXPLANTED AND REPLACED FOR ZIMMER BIOMET STEM.

  Patient problems: Injury

  MAUDE report 9902611 ↗
• InjuryMay 31, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PERI-PROTHETIC FRACTURE. HEAD AND LINER WERE REPLACED. DEVICES WON'T BE RETURNED.

  Patient problems: Injury

  MAUDE report 8660900 ↗
• InjuryJan 4, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE HEAD OF THE PROTHESIS CAME OUT OF THE POLYETHYLENE AND LED TO A DISLOCATION OF THE PROTHESIS. A REVISION SURGERY HAD TO BE PERFORMED WITH A NEW HEAD AND INSERT BEING FITTED.

  Patient problems: Discomfort

  MAUDE report 7166326 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K963509. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.