REFLECTION 71335158Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010482471), received between Apr 8, 2020 and Apr 8, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K211176, K932755); 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.

• 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 9936378 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K932755. 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.