REFLECTION 71323144Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010482648), received between Jan 6, 2021 and Aug 5, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Component Missing” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033442, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR PERFORMED ON (B)(6) 2021, IT WAS REPORTED THAT A PATIENT EXPERIMENTED A DISLOCATION OF THE IMPLANT. A REVISION SURGERY TOOK PLACE ON (B)(6) 2021 TO EVALUATE THE BEST WAY TO FIX THE PROBLEM AND THE ACETABULAR CUP AND LINER WERE REPLACED WITH ANOTHER COMPANY'S IMPLANTS. NEW SMITH AND NEPHEW FEMORAL HEAD IMPLANTED. IT IS UNKNOWN HOW FEMORAL HEAD WAS ABLE TO DISLOCATE OUT OF CONSTRAINED LINER. PATIENT CONDITION IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12285372 ↗
• InjuryJan 6, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A REFLECTION CONSTRAINED LINER CASE THE IMPLANT WAS LAID OUT ON THE TROLLEY IN FRONT OF THE SURGEON TO IMPLANT AND THE SURGEON REALIZED THAT THE REF CNSTR LNR ADPTR 50-52OD E WAS NOT WITH THE IMPLANT. AS HE HAD USED IT BEFORE HE RECALLED THE ADAPTER HAD PREVIOUSLY COME IN A SEPARATE BOX NOT IN THE BOX WITH THE LINER. AS THE IMPLANT WAS NOT USEABLE WITHOUT THE RING THE SURGEON CONVERTED TO A DUAL MOBILITY CUP AND COMPLETED THE SURGERY (WITH A COMPETITOR DEVICE). THERE WAS A DELAY OF LESS THAN 30 MIN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11126303 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033442, 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.