REFLECTION 71336452Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010454355), received between Apr 12, 2018 and Nov 7, 2022 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED PRONOUNCED OSTEOLYSIS IN THE AREA OF THE RIGHT ACETABULUM, PAIN AND CRACKING NOISES IN THE RIGHT LEG. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022, IN WHICH FRACTURE AND COMPLETE WEAR AND TEAR OF THE POLYETHYLENE INLAY WAS OBSERVED. IN ADDITION, METALLOSIS WAS OBSERVED ON THE SOCKET; A SAMPLE WAS COLLECTED AND TEST RESULTS REMAIN PENDING. PATIENT IS CURRENTLY IN SEVERE PAIN AND STILL UNABLE TO WALK WITHOUT CRUTCHES FOUR MONTHS POST-OPERATIVE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 15748769 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER LEFT THR PERFORMED ON (B)(6) 2021, THE PATIENT PRESENTED AN INFECTION WITH PREVIOUS PELVIC FRACTURE. THIS WAS ADDRESSED VIA REVISIONS SURGERY ON (B)(6) 2022. PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Hip Fracture; Unspecified Infection

  MAUDE report 13517741 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY, THE PATIENT PRESENTED AN INFECTION, SO A FIRST STAGE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REMOVE AND REPLACE AN UNKNOWN REFLECTION LINER ((B)(4)), A SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 3 ((B)(4)), A COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0 ((B)(4)) AND A REFLECTION THREE HOLE SHELL SIZE 52MM ((B)(4)). CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13080860 ↗
• InjuryOct 23, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING THA SURGERY, THE LINER CAN'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 10730402 ↗
• 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 10564112 ↗
• MalfunctionAug 12, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE LINER CANNOT MATCH WITH THE ACETABULAR CUP. BACKUP DEVICE WAS USED. NO INJURY REPORTED. DELAY GREATER THAN 30 MIN REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8883002 ↗
• InjuryJun 9, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER THR SURGERY, X-RAY FILM RESULTS SHOW THAT THE SCREW IS OUT OF THE OUTER CUP. AND DURING SURGERY, IT WASN'T FOUND.

  Patient problems: Injury

  MAUDE report 8681409 ↗
• MalfunctionNov 24, 2018No Apparent Adverse Event; No Apparent Adverse Event

  DURING RIGHT TOTAL HIP REPLACEMENT SURGERY, THE SCREW GOES THROUGH THE ACETABULAR OUTER CUP.

  Patient problems: No Information

  MAUDE report 8100345 ↗
• InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE DEVICE, THE NAILS PENETRATED INTO THE CUP AND THIS CAUSED ANATOMICAL PENETRATION TO THE PELVIS. A DELAY GREATER THAN 2 HOURS WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: Injury

  MAUDE report 7507230 ↗
• InjuryMay 11, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A DELAY GREATER THAN 1 HOUR OCCURED DURING A THR DUE TO CONNECTION PROBLEM BETWEEN THE IMPLANTS. A BACKUP DEVICE WAS FINALLY USED TO COMPLETE THE SURGERY.

  Patient problems: Injury

  MAUDE report 7506438 ↗
• InjuryApr 12, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT A DELAY LONGER THAN 30 MINUTES OCCURED DURING SURGERY BECAUSE THE INNER LINING COULD NOT BE INSTALLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7425836 ↗

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