REFLECTION 71336454Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010454362), received between Feb 6, 2018 and Dec 17, 2019 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, THE REFLECTION LINER COULDN'T BE IMPLANTED INTO THE CUP. FINALLY A R3 LINER AND CUP WERE USED TO COMPLETE THE SURGERY. NO INJURY OR IMPACT TO PATIENT REPORTED. DELAY OF 1 HOUR REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9482182 ↗
• MalfunctionNov 20, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, AFTER THE ACETABULAR CUP WAS IMPLANTED, THE LINER COULD NOT BE LOCKED. ANOTHER BACKUP S&N CUP WAS USED TO COMPLETE THE SURGERY (NO ADDITIONAL CUTS WERE MADE FOR THE CHANGE). THERE WAS A DELAY OF 31 TO 60 MIN, BUT THERE WAS NO IMPACT TO THE PATIENT BECAUSE OF IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9350109 ↗
• 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 8720166 ↗
• InjurySep 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED, THE HEAD POPPED OUT OF THE LINER. THE REFLECTION CUP, THE CONSTRAINED LINER, THE FEMORAL HEAD AND THE REFLECTION 30MM SCREWS WERE EXPLANTED.

  Patient problems: Injury

  MAUDE report 7916704 ↗
• InjurySep 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 ALLPOLY CEMENTED CUP, BUT SURGERY HAD A DELAY GREATER TAN 30 MINUTES.

  Patient problems: Injury

  MAUDE report 7862643 ↗
• MalfunctionSep 10, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DOCTOR IMPLANTED THE REF CUP DURING THE OPERATION THEN OPENED THE INSERT WHILE IT COULDN'T GET INTO THE CUP. UNDER THE CONDITION THAT THE PRODUCT CODE WAS CONSISTENT WITH THE OUTER CUP, IT WAS ALWAYS NOT IN PLACE. THE STAFF TEMPORARILY TOOK A NEW SET OF PRODUCTS, BUT IT WAS STILL CAN NOT BE IMPLANTED. THE DOCTOR TRIED TO TAKE THE PRODUCT OUT OF THE BODY, AND THE INSERT AND THE CUP WERE NOT IN PLACE OUTSIDE THE BODY. FINALLY A NEW OUTER CUP WAS OPENED AND THE INSERT WAS RIGIDLY IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7859888 ↗
• InjuryMay 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2018, 9:00 AM, IN LINFEN ORTHOPEDIC HOSPITAL DURING A TOTAL HIP REPLACEMENT, AFTER A 54MM REFLECTION SP3 ACETABULAR CUP WAS IMPLANTED, FOUND THE 54-56/28MM LINER CANNOT MATCH WITH THE 54MM CUP. SO REMOVED THE 54MM CUP, CHANGED TO IMPLANTED A 56MM REFLECTION SP3 ACETABULAR CUP, AND THE 54-56/28MM LINER WAS IMPLANTED SUCCESSFULLY, THE SURGERY WAS COMPLETED. 90MIN DELAY WAS REPORTED, AND INCREASED THE PATIENT BLOOD LOSS.

  Patient problems: Injury

  MAUDE report 7509695 ↗
• InjuryFeb 20, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED A DELAY GREATER THAN 120 MINUTES DURING A THR DUE TO LOCKING INCONVENIENT OF THE IMPLANT.

  Patient problems: Injury

  MAUDE report 7281560 ↗
• InjuryFeb 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DELAY GREATER THAN 2 HOURS WAS REPORTED DUE TO CONNECTION PROBLEMS BETWEEN IMPLANTS. TO CORRECT THIS SITUATION, THE SURGEON DECIDED TO IMPLANT A BACK UP DEVICE INSTEAD.

  Patient problems: Failure of Implant

  MAUDE report 7244263 ↗

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