R3, STIKTITE 71338668Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556022214), received between Nov 23, 2020 and Nov 15, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT HIP REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2015 DUE TO FAILED METAL-ON-METAL PROSTHESIS, PAIN AND ELEVATED METAL ION LEVELS, THE PATIENT EXPERIENCED AN HEMATOMA WHICH REQUIRED AN INCISION AND DRAINAGE PROCEDURE ON (B)(6) 2015. SEVERAL CLOTS AND SOME MINOR BLEEDING IN THE RIGHT HIP WERE REMOVED FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM.

  Patient problems: Hematoma

  MAUDE report 12813235 ↗
• InjuryOct 15, 2021Biocompatibility; Biocompatibility

  US LEGAL MDL: IT WAS REPORTED THAT AFTER A LEFT R3-THA CONSTRUCT WAS IMPLANTED ON (B)(6) 2018, PLAINTIFF EXPERIENCED OSTEOLYSIS WITH LOOSENING ACETABULAR COMPONENT, PSEUDOTUMOR AND ELEVATED COBALT AND CHROMIUM LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THESE ADVERSE EVENTS. DURING THE SURGERY LARGE AMOUNT OF CLOUDY STRAW-COLORED JOINT FLUID EMANATED FROM THE INCISION, THE TRUNNION WAS INSPECTED AND NOTED TO DEMONSTRATE BLACK METALLOSIS AND OSTEOLYSIS NEAR THE ACETABULAR COMPONENT AND FEMORAL COMPONENT WAS NOTICED. THE CUP, HEAD, LINER, AND SLEEVE WERE EXPLANTED AND REPLACE. THE STEM WAS WELL FIXED, SO IT WAS CONSERVED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 12639099 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A LOOSE, INFECTED FEMORAL COMPONENT. DURING THIS PROCEDURE THE IMPLANTED LINER WAS REMOVED AND A ANTIBIOTIC SPACER WAS PUT IN PLACE. THE PATIENT THEN UNDERWENT REVISION SURGERY, 5 OR 6 WEEKS LATER, DUE TO TIMEFRAME OF 2-STAGE REVISION. THE WHOLE S&N SET WAS REMOVED AND REPLACED.

  Patient problems: Impaired Healing; Joint Laxity; Osteolysis; Subluxation; Unspecified Infection

  MAUDE report 10884170 ↗

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.