Tandem 71326604Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010196569), received between Jan 27, 2021 and Apr 19, 2021 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K211176, K896580); 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. How this data works · Data updated Oct 13, 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.

• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION HEMIARTHROSPLASTY WAS PERFORMED DUE TO AN UNSPECIFIC INFECTION. A PRE-OPERATIVE PLAN WAS MADE TO DEBRIDE AS MUCH OF THE INFECTED TISSUE AS POSSIBLE AND ONLY REMOVE AND REPLACE THE TANDEM UNIPOLAR SLEEVE AND HEAD FROM THE EXISTING CONSTRUCT.

  Patient problems: Unspecified Infection

  MAUDE report 11689151 ↗
• InjuryJan 27, 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 ON THE PATIENT LEFT HIP ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED DUE TO INCREASINGLY PAINFUL LEFT HIP; FAILED LEFT REVISION TOTAL HIP REPLACEMENT WITH EXTENSIVE METALLOSIS AND RECURRENT DISLOCATIONS. THE PATIENT´S FIRST DISLOCATION OCCURRED ON (B)(6) 2019 AND WAS TREATED VIA OPEN REDUCTION. THE SECOND DISLOCATION OCCURRED ON (B)(6) 2019 AND WAS TREATED VIA CLOSED REDUCTION.

  Patient problems: Failure of Implant; Joint Dislocation; Metal Related Pathology; Pain; Pocket Erosion

  MAUDE report 11240866 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K896580. 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.