REFLECTION 71333346Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010479761), received between Sep 18, 2017 and Apr 8, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K022902, K211176); 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.

• InjuryApr 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO RECURRENT DISLOCATION. ON (B)(6) 2010, THE PATIENT HAD A RIGHT HIP DISLOCATION - WITH 45 DEGREES OF INTERNAL ROTATION, THE HIP DISLOCATED AT 90 DEGREES OF FLEXION. THE PATIENT UNDERWENT A CLOSED REDUCTION PROCEDURE. ON (B)(6) 2010, THE PATIENT HAD REVISION SURGERY DUE TO THE RIGHT HIP BEING UNSTABLE AND DISLOCATED.

  Patient problems: Injury

  MAUDE report 9936384 ↗
• InjuryApr 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT SUFFERING FROM RECURRENT RIGHT HIP DISLOCATIONS. THE PATIENT HAD A HISTORY OF MULTIPLE DISLOCATIONS PREVIOUS TO THIS ONSET OF EVENTS.

  Patient problems: Injury

  MAUDE report 9928565 ↗
• InjuryApr 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S HIP WAS WASHED OUT DUE TO INFECTION, THE PROSTHETIC LINER WAS REMOVED, AND TRIAL LINER AND FRESH TRIAL HEAD LEFT IN. NO DELAY OR INJURY REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 8512575 ↗
• InjurySep 18, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION THR WITH AN EXCHANGE OF THE FEMORAL HEAD AND ACETABULAR LINER. THE PATIENT COMPLAINED OF PAIN AND MRI TESTING SHOWED A FLUID POCKET AROUND THE PROXIMAL FEMUR. NO VISIBLE SIGNS OF DAMAGE WERE OBSERVED IN SURROUNDING TISSUES, ACETABULAR COMPONENT, NOR STEM TRUNNION.

  Patient problems: Injury; Swelling

  MAUDE report 6873115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022902, K211176. 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.