REFLECTION 71333373Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010455857), received between Dec 2, 2019 and Sep 16, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2012, THE PATIENT EXPERIENCED A FEELING OF WRONGNESS AND LINER WEAR. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) REF XLPE 28 0 DEG 46-48 SZ D AND ONE (1) OXINIUM FEM HD 12/14 28MM +0 WERE EXCHANGED FOR ONE (1) REF XLPE 28 20 DEG 46-48 D AND ONE (1) OXINIUM FEM HD 12/14 28MM +4. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 23061752 ↗
• InjuryAug 11, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2012, UPON REVIEW OF AN X-RAY, IT WAS OBSERVED THAT A REFLECTION XLPE 28MM INNER DIAMETER 0 DEGREE 46-48MM OUTER DIAMETER SIZE D LINER WAS SEVERELY WORN. IT IS UNKNOWN IF/HOW THIS ADVERSE EVENT WAS TREATED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. REVISION SURGERY IS BEING CONSIDERED BY THE SURGEON; HOWEVER, NO CONFIRMATION OF THIS DECISION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 15214360 ↗
• InjuryAug 11, 2022Degraded; Degraded

  IT WAS REPORTED THAT, AFTER A THR PROCEDURE, WHEN THE CUSTOMER REVIEWED X-RAYS, IT WAS IDENTIFIED THAT THE LINER WAS WORN SEVERELY. THE SURGEON IS CONSIDERING REVISION, BUT THE DATE IS UNDECIDED. IT IS UNKNOWN IF THIS ADVERSE EVENT HAS BEEN ADDRESSED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214006 ↗
• InjuryJun 24, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON 2012, A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 DUE TO LINER WEAR. THE REF XLPE 28 0 DEG 46-48 SZ D WAS EXPLANTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14808991 ↗
• InjuryFeb 8, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON THE (B)(6) 2012, A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 DUE TO SEVERE WEAR OF THE REF XLPE 28 20 DEG 46-48 D. THE REF XLPE 28 20 DEG 46-48 D WAS REPLACED. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE IS A BLACK SUBSTANCE ON THE LINER'S ARTICULAR SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480596 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED DUE TO WEAR. THE PATIENT EXPERIENCED FALLING. REFLECTION XLPE ACETABULAR LINER AND UNKNOWN FEMORAL HEAD DEVICES WERE EXPLANTED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICES. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11275895 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO WEAR. UNKNOWN HOW THE PROCEDURE FINISHED, IF OCCURRED A SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11056376 ↗
• InjuryNov 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A THA PROCEDURE, THE HOLE WORN THROUGH REFLECTION LINER. PROCEDURE FINISHED, WITHOUT DELAY, BY USING A 20 DEGREE LINER. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886849 ↗
• InjuryDec 2, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION, BECAUSE OF WEAR. THE PATIENT REQUIRES ABRASION LOSS OF THE LINER.

  Patient problems: Injury

  MAUDE report 9397079 ↗

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.