NA 71342644Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010652010), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K093363, K211176); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2022Biocompatibility; Biocompatibility

  US LEGAL BILATERAL PATIENT. IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2012, THE PATIENT UNDERWENT ANOTHER REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2021 DUE TO MECHANICAL COMPLICATION OF PROSTHETIC HIP IMPLANT, OSTEOLYSIS, METALLOSIS AND PERIPROSTHETIC FRACTURE. THE PRIMARY LEFT BHR WAS PERFORMED ON (B)(6) 2009. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s); Hip Fracture; Metal Related Pathology; Osteolysis

  MAUDE report 13896710 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093363, K211176. 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.