REFLECTION 71333324Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010455611), received between Feb 17, 2018 and Dec 29, 2021 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR, PERFORMED SIXTEEN YEAR AGO (2005), THE PATIENT EXPERIENCED 2 RECENT DISLOCATIONS, WITH THE LAST DISLOCATION APPROXIMATELY 3 WEEKS AGO. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO CHANGE REFLECTION 28MMID SIZE E XLPE 20 DEG LINER (CASE-(B)(4)) TO CONSTRAINED OPTION AND CHANGE COCR 12/14 FEM HEAD 28 +0 (CASE-(B)(4)). THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13110956 ↗
• InjurySep 21, 2020Difficult to Insert; Defective Device; Difficult to Insert; Defective Device

  IT WAS REPORTED THAT DURING A RIGHT THR PROCEDURE, AFTER IMPLANTING THE OUT CUP 71336450 (REF THREE HOLE SHELL 50MM), LINER 71742850 (REF LNR 28X50-52 20 DEG SZ E) COULDN'T BE IMPLANTED. TRY TO USE THE LINER 71333324 (REF XLPE 28 20 DEG 50-52 E), STILL DIDN'T WORK. TRY TO USE THE OUT CUP OF 71336452 (REF THREE HOLE SHELL 52MM), STILL DID NOT WORK. DUE TO OSTEOPOROSIS OF THE PATIENT, THE OUTER CUP WAS LOOSE AND COULD NOT BE TIGHTENED MANY TIMES, RESULTING IN PARTIAL LOSS OF THE POSTERIOR WALL BONE. FINALLY, THE REINFORCE RING AND BONE CEMENT CUP WERE USED TO COMPLETE THE SURGERY. IN ADDITION, THERE WERE THE BONE GRAFT AND HERCULES BONE CEMENT TO PREVENT INFECTION. A DELAY GREATER THAN 30 MIN WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient; Osteopenia/ Osteoporosis

  MAUDE report 10564089 ↗
• InjuryJul 23, 2020Defective Device; Incomplete or Inadequate Connection; Defective Device; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING THR PROCEDURE THE 28 MM LINER WAS NOT COMPATIBLE WITH REFLECTION SHELL SIZE 50. TRIED MULTIPLE TIMES BUT FAILED TO FIT. NO DELAY IN SURGERY TIME SINCE 32 MM LINER WAS AVAILABLE, IT WAS VERY SMOOTH TO FIT IN THE FIRST TRY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10312357 ↗
• InjuryOct 30, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RECURRENT DISLOCATIONS AND INSTABILITY. LINER AND HEAD WERE REMOVED. THIS PATIENT UNDERWENT A CLOSED REDUCTION ON (B)(6) 2011 AND A DISLOCATION ON (B)(6) 2013. IN ADDITION TO THIS THE PATIENT HAD A FALL IN (B)(6) 2013 AND PRESENTED TROCHANTERIC BURSITIS DUE TO THIS INCIDENT.

  Patient problems: Injury

  MAUDE report 9255835 ↗
• MalfunctionNov 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE REFLECTION XLPE 20 DEGREE OVERLAPPED ACETABULAR SIZE E DID NOT GET SEATED TO THE CORRESPONDING 52MM REFLECTION 3 HOLE ACETABULAR SHELL IN A PRIMARY THR. SURGEON STRUGGLED FOR ALMOST 45 MINUTES FOR GETTING IT LOCKED. FINALLY, THEY WERE FORCED TO REMOVE THE TWO SCREWS AND THE ACETABULAR SHELL BECAUSE OF THIS ISSUE (THOUGH THE ACETABULAR SHELL AND SCREWS FIXED PERFECTLY) AND IMPLANTED A SAME SIZE CEMENTED REFLECTION ALL POLY CUP WITH BONE CEMENT.

  Patient problems: No Information

  MAUDE report 8107736 ↗
• InjuryNov 14, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT SUFFERED SEVERAL DISLOCATIONS "ON" 2017. SPECIFIC DATE AND TREATMENT ARE UNKNOWN.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8070902 ↗
• InjuryNov 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT SUFFERED SEVERAL DISLOCATIONS ON 2017. SPECIFIC DATE AND TREATMENT ARE UNKNOWN.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8070262 ↗
• InjuryNov 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT SUFFERED SEVERAL DISLOCATIONS ON 2017. SPECIFIC DATE AND TREATMENT ARE UNKNOWN.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8070252 ↗
• InjuryNov 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT SUFFERED SEVERAL DISLOCATIONS ON 2017. SPECIFIC DATE AND TREATMENT ARE UNKNOWN.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8070171 ↗
• InjuryNov 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT SUFFERED SEVERAL DISLOCATIONS ON 2017. SPECIFIC DATE AND TREATMENT ARE UNKNOWN.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8070157 ↗
• InjuryNov 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT SUFFERED SEVERAL DISLOCATIONS ON 2017. SPECIFIC DATE AND TREATMENT ARE UNKNOWN.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8069055 ↗
• InjuryNov 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT SUFFERED SEVERAL DISLOCATIONS ON 2017. SPECIFIC DATE AND TREATMENT ARE UNKNOWN.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8068982 ↗
• InjuryNov 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT SUFFERED SEVERAL DISLOCATIONS ON 2017. SPECIFIC DATE AND TREATMENT ARE UNKNOWN.

  Patient problems: Injury; Joint Dislocation; Unspecified Infection

  MAUDE report 8068934 ↗
• InjuryNov 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT SUFFERED SEVERAL DISLOCATIONS ON 2017. SPECIFIC DATE AND TREATMENT ARE UNKNOWN.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8067853 ↗
• InjuryFeb 17, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE REFLECTION 50-52, THE ACETABULAR LINER IMPLANT IT COULD NOT LOCK WITH ACETABULAR CUP, THE SURGERY WAS EXTENDED FOR APPROXIMATELY 1 HOUR.

  Patient problems: Injury

  MAUDE report 7279475 ↗

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.