NA 71344248Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556022962), received between Feb 17, 2018 and May 26, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO PERIPROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8643151 ↗
• InjuryMay 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED POSSIBILITY FOR THE UNDERLYING HEMATOMA TO HAVE BECOME INFECTED FROM THE CELLULITIS, SUGGESTING THE DEVICE IS LIKELY TO BE INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 8643149 ↗
• InjuryMar 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN THE RIGHT HIP SINCE, UPON CT SCAN, IT WAS NOTICED THAT ONE OF THE PELVIC SCREWS WAS IN THE SOFT TISSUES REQUIRING FEMORAL MODULAR SLEEVE REVISION.

  Patient problems: Injury

  MAUDE report 8418629 ↗
• InjuryMar 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY ON THE RIGHT HIP DUE TO POSSIBLE INFECTION; IRRIGATION AND DEBRIDEMENT WERE PERFORMED ALONG WITH SLEEVE EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 8416906 ↗
• InjuryFeb 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO A SUBSIDED STEM. THE STEM, THE OXINIUN MODULAR HEAD AND THE TITANIUM MODULAR HEAD WERE REMOVED.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7279382 ↗

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.