NA 11915Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556003565), received between Aug 23, 2022 and Feb 28, 2024 — classified as 2 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K072817, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2024Contamination; Material Deformation; Adverse Event Without Identified Device or Use Problem; Contamination; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED PAIN AND WAS DIAGNOSED WITH PSEUDOTUMOR ON (B)(6) 2024. THE REOPERATION TO REMOVE THE PSEUDOTUMOR WAS SCHEDULED FOR (B)(6) 2024. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 18797855 ↗
• InjuryAug 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON (B)(6) 2008, PATIENT SUFFERED A FALL THAT CAUSED PAIN, A BONE FRACTURE AROUND THE STEM AND A DISLOCATION. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 WHERE THE UNIVERSAL FEMORAL HEAD COBALT CHROME 28MM 0MM EXTENSION WAS EXPLANTED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 15278027 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072817, 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.