REFLECTION 71358065Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010533173), received between Sep 22, 2021 and Mar 5, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A SECOND STAGE REVISION SURGERY, ONE (1) REF XLPE ALL PLY CUP 36 52 AND ONE (1) COCR 12/14 FEM HEAD 36MM +4 WERE EXPLANTED. THE REASON OF THE REVISION IS STILL UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837835 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR, A REVISION SURGERY WAS PERFORMED IN TWO STAGES, THE FIRST STAGE ON (B)(6) 2021 AND THE SECOND STAGE ON (B)(6) 2021. IN THE SECOND STAGE REVISION SURGERY, NINE (9) DEVICES WERE EXPLANTED, A REF XLPE ALL PLY CUP 36 52, A COCR 12/14 FEM HEAD 36MM +8, A CPCS PRI STD OFFSET 12/14 XSM, A ACC STD 125MM 5 CBL TROCH GRIP, A ACCORD 2.0MM COCR CABLE, AND FOUR (4) ACC 2.0MM COCR CABLES W/CLAMP. THE REASON TO PERFORM THE REVISION SURGERY AND THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12516521 ↗

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.