REFLECTION 71334056Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010197320), received between Nov 10, 2023 and Nov 10, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A THR REVISION SURGERY HAD TO BE PERFORMED DUE TO POLY WEAR AND OSTEOLYSIS OF THE POSTERIOR COLUMN, THE PRIMARY SURGERY HAD BEEN PERFORMED FIFTEEN (15) YEARS AGO. PATIENT WAS ADMITTED FOLLOWING A FALL. THE ACETABULAR COMPONENTS, RF INTERFIT ACET NH SZ 56, REF LNR 28ID 20 DEG SZ F, AND REF INTERFIT THRD HOLE COVER WERE EXPLANTED, AND REPLACED BY S+N IMPLANTS. SURGERY OUTCOME WAS SATISFACTORY, X-RAY SHOWED CAGE SITTING UP SLIGHTLY DUE TO SOME SUPERIOR OSTEOPHYTES. PATIENT HAS GONE TO REHAB AND HIP PAIN IS GONE. A SAMPLE FROM THE THEATER GREW STAPHYLOCOCCUS, SAID TO BE A LIKELY CONTAMINANT BUT TWO (2) WEEKS OF ANTIBIOTICS WERE PRESCRIBED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fall; Osteolysis

  MAUDE report 18110492 ↗

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