R3, STIKTITE 71338673Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556022184), received between Jan 25, 2019 and Jan 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K092386, 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.

• InjuryJan 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD TWO-STEP REVISION WHEREBY A SPACER WAS IMPLANTED ON (B)(6) 2015, FOLLOWED BY REMOVAL OF THE SPACER AND IMPLANTATION OF A NEW TOTAL HIP REPLACEMENT SYSTEM ON (B)(6) 2016. WITH THE EXCEPTION OF THE SPACER, IT HAS NOT BEEN POSSIBLE TO CONFIRM PRECISE DATES WHEN EACH COMPONENT WAS EXPLANTED. A RELATED, PREVIOUS BHR REVISION WAS REPORTED UNDER MDR REFERENCE 3005975929-2018-00340.

  Patient problems: Injury

  MAUDE report 8279023 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092386, 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.