REFLECTION 71333325Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010455628), received between Jul 17, 2017 and Dec 3, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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.

• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2007, THE PATIENT EXPERIENCED A BONE BREAKAGE AROUND THE STEM. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY PERFORMED ON (B)(6) 2025, IN WHICH A COMPETITOR'S PLATE AND CABLE WARE USED TO FIX THE BREAKAGE. WHITE SMALL MATERIAL WAS FOUND IN THE SURGICAL FIELD. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Periprosthetic fracture

  MAUDE report 23703496 ↗
• InjuryAug 23, 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) 2008, PATIENT SUFFERED A FALL THAT CAUSED PAIN, A BONE FRACTURE AROUND THE STEM AND A DISLOCATION. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 WHERE THE REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F WAS EXPLANTED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 15278102 ↗
• InjuryJun 20, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY THE LINER NOT LOCKED PROPERLY IN TO THE SHELL. THEY USED ANOTHER LINER THAT ALSO NOT LOCKED. THEY REMOVED REFLECTION SHELL 54 AND USED R3 SHELL 56 AND LINER. 30 MINUTES OF DELAY DUE TO THIS INCIDENT. A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8720155 ↗
• MalfunctionOct 3, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE REFLECTION MICROSTABLE LOCKING MECHANISM LINER FAILED TO LOCK INSIDE WITH THE REFLECTION CUP DURING TOTAL HIP REPLACEMENT PROCEDURE.THE SURGEON FOUND IT DIFFICULT ONCE DISLOCATION WAS DONE WITH THE ORIGINAL POLAR PROSTHESIS.THE SURGEON COULD NOT FIX THE LINER SINCE IT WAS NOT LOCKING PROPERLY. ALMOST ONE HOUR TWENTY MINUTES WAS SPENT ON THE TABLE, IMPLANTS WERE REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931883 ↗
• MalfunctionSep 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT LINER IMPLANT DIDN'T LOCK WITH THE ACETABULAR CUP. THE SURGEON TRIED MANY TIMES TO GET IT SEATED IN THE CUP, WHICH WAS ALREADY IMPLANTED WITH A 6.5MM CANCELLOUS SCREW. THEN HE REMOVED THE SCREW, ACETABULAR CUP AND THE LINER. FINALLY COMPLETED THE PROCEDURE BY FIXING A REFLECTION ALL POLY CEMENTED CUP, BUT SURGERY HAD A DELAY GREATER TAN 30 MINUTES.

  Patient problems: Injury

  MAUDE report 7862646 ↗
• MalfunctionAug 27, 2018Difficult to Open or Close

  IT WAS REPORTED THAT THE LINER COULD NOT BE LOCKED, FINALLY A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7820720 ↗
• InjuryJul 17, 2017Connection Problem; Connection Problem

  THE LINER FAILED TO LOCK INSIDE. HENCE, THE CUP WAS REMOVED AND REAMED TO THE NEXT SIZE OF THE ACETABULAM. THE NEXT SIZE OF THE CUP WAS OPENED AND THE CORRESPONDING LINER & THEN THE PROCEDURE WAS COMPLETED. SURGERY WAS EXTENDED 30 TO 45 MINUTES.

  Patient problems: No Information

  MAUDE report 6717018 ↗

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.