REFLECTION 71336448Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010454331), received between Nov 21, 2017 and Nov 30, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2013 WITH A REF THREE HOLE SHELL 48MM ((B)(4)), REF XLPE 22 0 DEG 46-48 SZ ((B)(4)) AND A OXINIUM FEM HD 12/14 28MM +4 ((B)(4)), A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO OSTEOLYSIS. THE PRODUCTS WERE REPLACED TO COMPETITOR'S PRODUCTS. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Osteolysis

  MAUDE report 12898342 ↗
• InjuryMar 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION AND PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7358969 ↗
• InjuryNov 21, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7047971 ↗

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