REFLECTION 71334252Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010452801), received between Nov 3, 2018 and Mar 1, 2022 — classified as 1 injury, 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K211176, K990666); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED DISLOCATION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY TO EXCHANGE THE REF NH HA SHELL SZ 52MM, WITH COMPETITOR PRODUCTS. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13635862 ↗
• InjuryNov 3, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT UNDERGONE REVISION THR SURGERY FOR RECURRENT DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8036165 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K990666. 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.
• Z-2297-2016 · Jul 6, 2016 · Terminated
  SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revis