R3, STIKTITE 71338665Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556021491), received between Jan 25, 2019 and Oct 4, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT HIP REVISION SURGERY PERFORMED ON (B)(6) 2018 TO REMOVE AN ANTIBIOTIC SPACER WITH CONVERSION TO THA DEFINITIVE IMPLANTS, THE PATIENT SUSTAINED A RECURRENT PERIPROSTHETIC JOINT INFECTION THAT REQUIRED A RE-REVISION OF THE JOINT PROSTHESIS ON (B)(6) 2018. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20375952 ↗
• InjuryMar 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2023, IN WHICH ONE (1) ANTHOLOGY HO POROUS SZ 8, ONE (1) OXINIUM FEM HD 12/14 32MM +8, ONE (1) R3 20 DEG XLPE ACET LNR 32MM X 52MM AND ONE (1) R3 MULTI HOLE ACETABULAR SHELL 52MM WERE EXPLANTED. PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16569580 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ''US LEGAL MDL'': IT WAS REPORTED THAT, AFTER 3 MOTHS OF A REVISION SURGERY PERFORMED ON (B)(6) 2016 (COVERED UNDER (B)(4)), THE PATIENT EXPERIENCED PAIN. CLINICAL EXAMS REVEALED RIGHT HIP HETEROTOPIC OSSIFICATION. HIP ASPIRATION TEST WAS PERFORMED AND CAME NEGATIVE FOR INFECTION. THE EVENT WAS TREATED WITH INJECTIONS, ANTI-INFLAMMATORY TREATMENT, AND PHYSICAL THERAPY. THE PATIENT OUTCOME IS STABLE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 11940872 ↗
• InjuryJun 23, 2020Misconnection; Misconnection

  IT WAS REPORTED THAT AFTER SURGERY THE ACETABULAR SCREW EXITED THE SCREW HOLE IN THE 52MM R3 MULITHOLE CUP, THIS WAS SEEN IN AN X-RAY. THE SURGEON REPORTED THAT BOTH SCREWS WERE FIRMLY SEATED AT THE BOTTOM OF THE HOLE WITH EXCELLENT PURCHASE. NEITHER SCREW APPEARED TO GO BEYOND THE CUP AT THE TIME THEY WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 10183169 ↗
• InjurySep 2, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION SURGERY WAS PERFORMED DUE TO CUP LOOSENING. THE CUP WAS EXCHANGED TO COMPETITOR'S PRODUCT.

  Patient problems: Injury

  MAUDE report 8954174 ↗
• MalfunctionJun 27, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT AFTER SURGERY THE POST OPERATIVE FILM LOOKS LIKE THE SCREW WENT BEYOND THE SHELL. THERE IS NO INFORMATION THAT AN INTERVENTION OCCURRED DUE TO THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8741895 ↗
• MalfunctionJan 25, 2019Calibration Problem; Unintended Movement; Calibration Problem; Unintended Movement

  IT WAS REPORTED THAT AFTER A TOTAL HIP REPLACEMENT PROCEDURE, POST OPERATIVE FILM SHOWED THAT THE SCREW HAD GONE COMPLETELY THROUGH THE SHELL. NO DELAY REPORTED. NO REVISION SURGERY PERFORMED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8279016 ↗

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.