REFLECTION 71358034Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010474247), received between Aug 11, 2017 and Oct 16, 2024 — classified as 7 injuries.

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 (K002747, 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. How this data works · Data updated Oct 13, 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 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED INFECTION AND DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A REF ALL POLY 32ID 49OD XLPE, CPCS COCR PRIM SO 12/14 SZ 2, COCR 12/14 FEM HEAD 32 + 0 AND A CPCS DIST CENT SZ 12MM WERE EXCHANGED AND COMPETITOR SYSTEM WAS IMPLANTED DUE TO CHRONIC INFECTION AND CHANGING TO A DUAL MOBILITY PROSTHESIS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 20466362 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "ACUTE ACETABULAR PROTRUSION: THE HARDINGE APPROACH FOR IMPLANT REMOVAL AND ONE-STAGE HIP RECONSTRUCTION¿, ONE (1) PATIENT AFTER A TKA SURGERY ON THE LEFT HIP ON (B)(6) 2022 DUE TO ACUTE PELVIC PENETRATION OF THE ACETABULAR SHELL, SUSTAINED THREE (3) DISLOCATIONS DURING SIMPLE MANEUVERS (GETTING OUT OF BED AND SITTING ON THE TOILET) DUE TO STEMMED FROM AN ISSUE WITH THE SOFT TISSUE TENSION. PATIENT REQUIRED REVISION SURGERY ON (B)(6) 2022 IN WHICH THE ACETABULAR CUP WAS CHANGED TO A CONSTRAINED LINER WHICH WAS CEMENTED INTO THE CAGE. SINCE THIS REVISION, THERE HAVE BEEN NO FURTHER DISLOCATIONS, AND THE PATIENT IS USING A ZIMMER FRAME FOR WALKING WHILE AWAITING THA ON THE OPPOSITE SIDE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 19448660 ↗
• InjuryDec 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR WAS PERFORMED ON (B)(6) 2012 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION AND PAIN. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6)2013. DURING THIS PROCEDURE, THE ACETABULAR CUP AND FEMORAL STEM WERE REMOVED AND REPLACED WITH UNKNOWN COMPONENTS. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16048741 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HIP REPLACEMENT SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING A TWO REVISION SURGERIES, THE LATEST ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IN UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12046418 ↗
• InjurySep 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY DUE TO INFECTION. PATIENT HAD RECENTLY A SECOND REVISION FOR INFECTION ON SAME HIP. UNFORTUNATELY THE PATIENTS INFECTION PROGRESSED LEADING TO TODAY'S 3RD REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 7919798 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. ONLY THE FEMORAL HEAD AND POLY CUP WERE CHANGED IN THE REVISION. THE CPCS STEM STAYED IN.

  Patient problems: Joint Dislocation

  MAUDE report 7630121 ↗
• InjuryAug 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF INFECTED RIGHT TOTAL HIP ARTHROPLASTY. THE PATIENT UNDERWENT A REMOVAL OF RIGHT TOTAL HIP ARTHROPLASTY, PLACEMENT OF UNIPOLAR CEMENT SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 6790239 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002747, 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.