R3 71338704Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556113042), received between Jan 7, 2019 and Sep 8, 2019 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2019Unstable; Unstable

  IT WAS REPORTED A REVISION SURGERY, PERFORMED DUE TO INSTABILITY.

  Patient problems: Injury

  MAUDE report 8973374 ↗
• InjuryJan 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY THR IN (B)(6) 2018 AND DUE TO A DISLOCATION IN (B)(6), AN OPEN REDUCTION WAS PERFORMED.

  Patient problems: Joint Dislocation

  MAUDE report 8226107 ↗
• InjuryJan 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY THR IN (B)(6) 2018 AND PATIENT HAD A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8226047 ↗
• InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY THR IN (B)(6) 2018 AND PATIENT HAD A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8223631 ↗
• MalfunctionJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY "THR" IN (B)(6) 2018, AND PATIENT HAD A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8223111 ↗
• InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY THR IN (B)(6) 2018 AND PATIENT HAD A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8222895 ↗
• InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY THR IN (B)(6) 2018 AND PATIENT HAD A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8222765 ↗
• InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY THR IN (B)(6) 2018 AND PATIENT HAD A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8222392 ↗
• InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY THR IN (B)(6) 2018 AND PATIENT HAD A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8222276 ↗
• InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY THR IN (B)(6) 2018 AND IT HAD DISLOCATED SEVERAL TIMES SINCE. A REVISION SURGERY WAS PERFORMED TO EXCHANGE LINER AND FEMORAL HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 8222152 ↗

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.