REFLECTION 71333323Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010455604), received between Apr 11, 2017 and Oct 23, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2012, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO BONE FRACTURE AFTER PATIENT'S FALL. THE REF XLPE 28 20 DEG 46-48 D WAS REMOVED. THE COMPETITOR'S STEM WAS ALSO REMOVED. THE SURGEON DOESN'T THINK PRODUCTS FAILURE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 23364718 ↗
• MalfunctionAug 3, 2020Difficult to Insert; Defective Device; Difficult to Insert; Defective Device

  IT WAS REPORTED THAT DURING SURGERY THE REFLECTION XLPE LINER WAS NOT FITTING/ENGAGING TO ITS CORRESPONDING REFLECTION SHELL. HCP TRIED EVERYTHING TO GET IT ENGAGED BY CLEANING THE SHELL, CLEARING SOFT TISSUES FROM SHELL. A DELAY OF LESS THAN 30 MIN WAS REPORTED. S&N BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10355738 ↗
• InjurySep 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A RIGHT HIP REVISION SURGERY OF SMF STUDY WAS PERFORMED DUE TO PAIN AND METAL IONS IN BLOOD.

  Patient problems: Injury

  MAUDE report 9083517 ↗
• InjuryMar 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION AND PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7358952 ↗
• InjuryApr 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO PAIN CAUSED BY DISLOCATION.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 6483136 ↗

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.