R3, STIKTITE 71338669Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556020364), received between Apr 25, 2022 and Apr 25, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

• InjuryApr 25, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A THR ON AN UNKNOWN DATE, PATIENT EXPERIENCED INCREASED HIP PAIN AND SWELLING. X-RAYS SHOW FRACTURE AND TESTS PERFORMED REVEAL POTENTIAL INFECTION,. A REVISION WAS PERFORMED ON (B)(6) 2022, TREATMENT NOT DECIDED YET. OUTCOME: RESOLVING. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Failure of Implant; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 14192054 ↗

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.