REFLECTION 71323114Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010510884), received between May 18, 2017 and Mar 9, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Fracture

  IT WAS REPORTED THAT, AFTER A REVISION HIP SURGERY HAD BEEN PERFORMED IN 2017, THE PATIENT EXPERIENCED PAIN, DISCOMFORT AND LIMITED MOBILITY DUE TO A DISLOCATED HIP, AND IT APPEARS ON X-RAY THAT THE LOCKING RING OF THE CON LNR 0DEG 26ID 50-52OD SZ E HAS BROKEN, AND THE COCR 12/14 FEM HEAD 26 + 8 HAS MIGRATED SUPERIORLY. THE ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON, IN WHICH THE CON LNR 0DEG 26ID 50-52OD SZ E WAS REMOVED AND A CEMENTED POLARCUP WAS INSERTED INTO THE EXISTING SHELL. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 24545599 ↗
• InjuryMar 29, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED ON 2004, THE PATIENT EXPERIENCED DISLOCATION OF HEAD FROM WITHIN CONSTRAINED LINER. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH IT WAS FOUND THAT THE CON LNR 0DEG 26ID 50-52OD SZ E RING WAS BROKEN AND SEPARATED. IT WAS HARD TO TELL EXACTLY HOW MUCH WEAR THE LINER HAD AND WHETHER THIS WAS A FACTOR IN THE DISLOCATION OF THE THA. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13945671 ↗
• InjuryMar 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 CON LNR 0DEG 26ID 50-52OD SZ E, WITH COMPETITOR PRODUCTS. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13635916 ↗
• InjuryAug 9, 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 12294329 ↗
• InjuryOct 8, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THE FIRST REVISION TKA SURGERY WAS ON (B)(6) 2018. PATIENT SUFFERED DISLOCATION OF FEMORAL HEAD AND RETAINER RING FROM ACETABULAR SHELL AND CONSTRAINED LINER CONSTRUCT. PRIMARY SURGERY DATE UNKNOWN. SECOND REVISION (B)(6) 2020. NO INJURY REPORTED EXCEPT NEED FOR REVISION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 10653086 ↗
• InjuryNov 18, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR DISLOCATION CAUSED BY A BROKEN RING

  Patient problems: Injury

  MAUDE report 7043793 ↗
• InjuryMay 18, 2017Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED A SURGERY WAS DELAYED BY MORE THAN ONE HOUR DUE TO THE LOCKING MECHANISM ON THE RING BREAKING WHEN IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6577038 ↗

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.