REFLECTION 71333374Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010455864), received between Apr 12, 2021 and Apr 12, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K002747, 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. How this data works · Data updated Oct 13, 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 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT TO PRIMARY TOTAL HIP REPLACEMENT ON (B)(6) 1998. RECENTLY, THE PATIENT COMPLAINED OF PAIN, AND A REVISION SURGERY WAS PERFORMED. THE REFLECTION LINER 28MM (CASE-(B)(4)) AND THE COCR FEMORAL HEAD (CASE-(B)(4)) WERE REVISED. THE EXPLANTED IMPLANTS WERE REPLACED USING A REFLECTION LINER 32 MM AND AN OXINIUM FEMORAL HEAD. DURING REVISION WAS FOUND THAT THE ORIGINAL LINER HAD WORN AND WAS CAUSING INSTABILITY. THE OUTCOME OF THE PATIENT IS UNKNOWN

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 11648410 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002747, 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.