REFLECTION 71333334Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010455673), received between Nov 16, 2017 and Dec 2, 2022 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2022Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON (B)(6) 2009, A REVISION SURGERY WAS REQUIRED ON (B)(6) 2021 TO REPLACE AN OLD REFLECTION LINER (REF REQUIRED 32 20 DEG 50 52 E) THAT WAS CRACKED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15901325 ↗
• InjuryDec 31, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT THR PERFORMED ON (B)(6) 2019 DUE TO DEGENERATIVE ARTHRITIS, PATIENTS COMPLAINTS OF PAIN. X-RAYS AND BONE SCAN CONFIRMED ECCENTRIC ACETABULAR WEAR WITH SUPERIOR MIGRATION OF THE FEMORAL HEAD COMPATIBLE WITH EARLY POLY-DEGRADATION. PATIENTS UNDERWENT REVISION SURGERY ON (B)(6) 2021 IN WHICH THE FEMORAL HEAD AND LINER WERE EXPLANTED, AND NEW SMITH-NEPHEW DEVICES WERE IMPLANTED IN ITS PLACE. THE PATIENTS OUTCOME IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11101217 ↗
• InjuryOct 23, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A THA SURGERY, THE LINER COULDN'T BE PLACED SMOOTHLY AFTER THE SURGEON IMPLANTED THE REFLECTION ACETABULAR SYSTEM. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO HARM OR INJURY REPORTED ON PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10730506 ↗
• InjuryApr 22, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  US LEGAL: IT WAS REPORTED THAT PATIENTS THA GOT INFECTED. REVISION SURGERY AND FEMUR AND ACETABULUM WERE DEBRIDED AND LATER TREATED WITH A GIRDLESTONE PROCEDURE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9988930 ↗
• MalfunctionDec 24, 2019Misconnection; Misconnection

  IT WAS REPORTED THAT DURING A THR SURGERY, THE DOCTOR PREPARED ACETABULUM AND TOOK A TRIAL OF CUP SIZE 50. IT WAS GOOD AND FIXED WELL SO HE TOOK THE ORIGINAL REFLECTION SHELL AND IT FIXED WELL. HE THEN PUT A 25MM SCREW FOR BETTER FIXATION, THEN FIXED LINER FOR 32 MM HEAD. LATER HE PREPARED THE FEMUR FIX STEM AND TOOK TRIAL FOR THE HEAD AND REDUCED THE HIP JOINT. WHEN HE DISLOCATED THE HIP TO PUT THE ORIGINAL HEAD REFLECTION SHELL, THE LINER CAME OUT AND THE SCREW REMAINED INSIDE THE BONE (IT WAS LATER REMOVED). HE TRIED TO FIX IT AGAIN BUT DID NOT SUCCEED AND THEN HE TOOK SIZE 54 MM. THIS CAUSED A DELAY OF THIRTY MINUTES TO AN HOUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9517193 ↗
• MalfunctionSep 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. THE WOMAN HAD A COMPETITOR DEPUY STEM IN AND FRACTURED HER FEMUR. SHE HAD A PROXIMAL FEMUR PROCEDURE AND DR. REMOVED A REFLECTION XLPE SIZE E (32 I.D X 50-52MM) AND REPLACED IT WITH A NEW ONE. THERE WAS NO IMPLANT FAILURE OF THE LINER. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9104564 ↗
• MalfunctionMar 18, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY, LINER DOES NOT MATCH THE REQUIRED LINER TYPE FOR THE SURGERY, RESULTING IN A DELAY OF ONE HOUR. NO SUBSTANTIAL DAMAGE WAS CAUSED TO THE PATIENT. SURGERY WAS COMPLETED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430595 ↗
• InjuryNov 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. MECHANICAL FALL SECONDARY TO ETOH (ALCOHOL), FELL ON RIGHT SIDE, CAUSING PERIPROSTHETIC FRACTURE. AFTERWARDS, REPLACEMENT OF SHELL AND LINER WAS PERFORMED DUE TO RECURRENT DISLOCATIONS.

  Patient problems: Joint Dislocation

  MAUDE report 8068718 ↗
• InjuryMay 19, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY THE LINER WASN¿T TIGHT, A BACKUP DEVICE WAS USED BUT PRESENTED THE SAME FAILURE MODE. THE SURGERY HAD A DELAY FOR MORE THAN 2 HOURS.

  Patient problems: No Information

  MAUDE report 7528545 ↗
• InjuryMay 19, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY THE LINER WASN¿T TIGHT, A BACKUP DEVICE WAS USED BUT PRESENTED THE SAME FAILURE MODE. THE SURGERY HAD A DELAY FOR MORE THAN 2 HOURS.

  Patient problems: No Information

  MAUDE report 7528499 ↗
• InjuryNov 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION. SURGEON FOUND THAT THE POLY INSERT WAS NOT LOCKED INTO CUP PROPERLY SO IT WAS REPLACED WITH NEW ONE.

  Patient problems: Unspecified Infection

  MAUDE report 7037135 ↗

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.