R3, STIKTITE 71338666Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556021804), received between Dec 3, 2018 and Jun 17, 2024 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA ON (B)(6) 2021, PATIENT REQUIRED READMISSION FOR AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2021 DUE TO INFECTION AND INFLAMMATORY REACTION OF INTERNAL RIGHT HIP PROSTHESIS. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19554518 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON (B)(6) 2021. THE PATIENT EXPERIENCED RECURRENT ANTERIOR DISLOCATION OF THE RIGHT HIPS; THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REVISE THE R3 MULTI HOLE ACETABULAR SHELL 54MM, OR3O DUAL MOBILITY LINER 42/54 AND THE OR3O DM XLPE INSERT 28/42. SURGICAL OUTCOME WAS SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13282073 ↗
• InjuryJan 29, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED TWO DISLOCATIONS THAT REQUIERED RELOCATION OF THE JOINT. FOR THE THIRD DISLOCATION THEREFORE PATIENT HAD TO BE TAKEN TO THE OR. A REVISION SURGERY WAS PERFORMED TO TREAT THIS EVENT. THE SYNERGY STEM WAS WELL FIXED, BUT THE SURGEON FELT LIKE THE R3 MULTI HOLE ACETABULAR SHELL 54MM WAS MALPOSITIONED; THEREFORE, IT WAS REMOVED. THE R3 20 DEG XLPE ACET LNR 36MM X 58MM AND COCR 12/14 FEM HEAD 36MM +0 WERE ALSO REMOVED. THE SURGEON REPOSITIONED THE CUP AND IMPLANTED A REDAPT MODULAR CUP WITH OR30 ASSEMBLY, ACETABULAR SCREWS AND 28MM OXINIUM HEAD. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Joint Dislocation

  MAUDE report 11250218 ↗
• MalfunctionMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY THE IMPLANTS DID NOT SEAT. A BACK DEVICE WAS AVAILABLE AND LESS THAN 30 MINUTES DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9820980 ↗
• MalfunctionMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY THE IMPLANTS DID NOT SEAT. A BACK DEVICE WAS AVAILABLE AND LESS THAN THIRTY MINUTES DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9820851 ↗
• InjuryMay 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. CUP, LINER AND HEAD WERE REPLACED. THE SURGEON DOES NOT BLAME THE DEVICES.

  Patient problems: Injury

  MAUDE report 8597365 ↗
• InjuryDec 11, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO CUP LOOSENING CONFIRMED BY X RAYS. DURING THE FIRST STAGE REVISION OF THE LEFT HIP, THE SURGEON EXTRACTED A R3 MULTIHOLE CUP, LINER AND FEMORAL HEAD AND REFLECTION SCREWS. THE XLPE LINER SHOWS DAMAGE TO POSTERIOR WALL AND THE FEMORAL HEAD SHOWS DAMAGE. METALLOSIS COULD BE DETECTED IN THE SOFT TISSUE OF THE ACETABULUM.

  Patient problems: Injury

  MAUDE report 8150387 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MULTIHOLE CUP WAS IMPLANTED, AND THE POLYS WAS UNABLE TO SEAT IN THE SHELL. DR CHECKED THAT THE SCREWS WERE NOT IMPEDING SEATING, THE SHELL WAS REMOVED AND REPLACED WITH REDAPT SHELL. DELAY GREATER THAN 30 MIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8125193 ↗

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.