REFLECTION 71333397Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010479747), received between Sep 5, 2019 and Jun 8, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  IT WAS REPORTED THAT, AFTER A THR PROCEDURE HAD BEEN PERFORMED IN 2006, THE PATIENT WAS EXPERIENCING AN UNSPECIFIED ADVERSE EVENT. A REVISION SURGERY WAS SCHEDULED (B)(6) 2022 TO REPLACE THE WORN OUT 16-YEAR-OLD REF LINER. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14630141 ↗
• InjurySep 12, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A POLY WEAR. POLY AND HEAD WERE REMOVED.

  Patient problems: Injury

  MAUDE report 9008450 ↗
• InjurySep 5, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO POLY WEAR. LINER AND HEAD WERE REMOVED. PRIMARY SURGERY WAS PERFORMED ON 2003.

  Patient problems: Injury

  MAUDE report 8967582 ↗

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.