R3, STIKTITE 71338663Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556021941), received between Nov 20, 2017 and May 3, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A DISLOCATION OF A HIP REPLACEMENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A R3 MULTI HOLE ACETABULAR SHELL 48MM WAS EXCHANGED TO A DUAL MOBILITY CONSTRUCT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25064273 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR PROCEDURE, PATIENT PRESENTED PROTRACTED WOUND HEALING. MEDICATION THERAPY AND PROLONGED HOSPITALIZATION WERE NECESSARY TO TREAT THIS PROBLEM. IMPLANTS REMAINED IN PLACE.

  Patient problems: Impaired Healing

  MAUDE report 10815819 ↗
• InjuryFeb 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN, SWELLING, DISASSOCIATION OF THE CUP AND DISLOCATION OF THE INSERT.

  Patient problems: Injury

  MAUDE report 9718898 ↗
• InjuryJul 5, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT SUFFERED AN ACETABULAR SHELL DISLOCATION. THE EVENT WAS RESOLVED WITH REVISION SURGERY. CUP HAS BEEN DESTROYED AND IS NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: Joint Dislocation

  MAUDE report 7663695 ↗
• InjuryNov 20, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO KNEE DISLOCATION.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7044983 ↗

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.