REFLECTION 71336450Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010454348), received between Dec 6, 2019 and Oct 11, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K211176, K960094); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY 4-5 YEARS AFTER A THA REVISION SURGERY WAS PERFORMED ON THE PATIENT¿S LEFT HIP ON (B)(6) 2018 DUE TO MECHANICAL FAILURE OF THE FEMORAL COMPONENT, THE PATIENT EXPERIENCED A CHRONIC INFECTED LEFT THA WITH A DRAINING SINUS FROM THE DISTAL ASPECT OF THE INCISION WITH PURULENT MATERIAL SURROUNDING THE ENTIRE PROSTHESIS, ALL ASSOCIATED TO A GROWING GAMMA HEMOLYTIC STREPTOCOCCUS SP. A REVISION SURGERY WITH EXTENSIVE IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, BOTH THE FEMORAL AND ACETABULAR COMPONENTS WERE REMOVED AND REPLACED WITH A NEW THA PROSTHESIS. INTRAOPERATIVELY, THERE WAS BONE LOSS INVOLVING THE LATERAL ASPECT OF THE FEMORAL DIAPHYSIS IN THE JUNCTION OF THE PROXIMAL AND CENTRAL THIRD OF THE FEMUR AND EROSION OF THE CORTICAL SHAFT OF THE FEMUR WAS FOUND DUE TO THE ONGOING INFECTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY COMPLICATIONS.

  Patient problems: Bacterial Infection; Osteomyelitis; Purulent Discharge

  MAUDE report 15577888 ↗
• InjurySep 21, 2020Defective Device; 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: No Known Impact Or Consequence To Patient

  MAUDE report 10564133 ↗
• 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 30 MINUTES TO AN HOUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9517163 ↗
• MalfunctionDec 6, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, HOLE COVER PASSED COMPLETELY THROUGH THE ACETABULAR SHELL AND COULD NOT BE RETRIEVED AS SHELL WAS ALREADY SCREWED INTO PLACE. NO INJURY AND A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS CONCLUDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9426262 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K960094. 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.
• Z-1066-2014 · Jan 23, 2014 · Terminated
  Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rh