REFLECTION 71323125Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010480057), received between Sep 14, 2017 and Apr 8, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K021803, 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 6 most recent of 6 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) OF 2010, AN OPEN REDUCTION AND REVISION SURGERY WERE PERFORMED DUE TO A CONSTRAINED LINER. THEREFORE, THE CONSTRAINED LINER WAS REMOVED. THE DOCTOR DECIDED TO REMOVE THE ACETABULAR SHELL AS WELL, EVEN THOUGH IT WAS WELL FIXED. POSTOPERATIVELY, THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Injury

  MAUDE report 9936283 ↗
• InjuryApr 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT SUFFERING FROM A RIGHT HIP DISLOCATION. THE PATIENT HAD A HISTORY OF MULTIPLE DISLOCATIONS OCCURRING ON THE SAME HIP SIDE.

  Patient problems: Injury

  MAUDE report 9928559 ↗
• InjuryApr 22, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. PATIENT HAD A PREVIOUS REVISION SURGERY DUE TO A BROKEN LINER ON "9/5/2018".

  Patient problems: Injury

  MAUDE report 8536195 ↗
• InjuryAug 30, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. THE HEAD POPPED OUT OF THE LINER.

  Patient problems: No Information

  MAUDE report 7833155 ↗
• InjuryNov 27, 2017Fracture; Fracture

  IT WAS REPORTED A REVISION HIP SURGERY WAS PERFORMED DUE TO THE RING OF THE LINER BEING BROKEN BY IMPINGEMENT. THE LINER WAS EXCHANGED DURING THE REVISION.

  Patient problems: Injury

  MAUDE report 7061900 ↗
• InjurySep 14, 2017Break; Unintended Movement; Break; Unintended Movement

  REVISION SURGERY WAS PERFORMED DUE TO FRACTURE IMPLANT.

  Patient problems: Pain

  MAUDE report 6865122 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021803, 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.