REFLECTION 71336456Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010454379), received between Jun 1, 2018 and Apr 19, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K211176, K960094); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNKNOW DATE, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19142493 ↗
• InjuryNov 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REVISION DUE TO PAIN THAT BECAME PROGRESSIVELY WORSE. THE WHOLE SYSTEM WAS REPLACED.

  Patient problems: Pain

  MAUDE report 9362833 ↗
• MalfunctionFeb 1, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TWO LINERS CONTINUOUSLY CAN'T BE IMPLANTED INTO THE OUTER CUP. THE SURGEON PUSHED TOO HARD, RESULTING IN THE FRACTURE OF THE POSTERIOR COLUMN OF THE ACETABULUM. AFTER THAT, THE OUTER CUP OF THE ACETABULUM WAS REPLACED, AND THE BIOLOGICAL ACETABULUM WAS FIXED WITH BONE CEMENT. THIS WAS FOUND DURING SURGERY. PROCEDURE DELAYED OVER 30 MINUTES. SMITH AND NEPHEW BACK UP USED. NO PIECES REMAIN INSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8296708 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SUGERY WAS PERFORMED DUE TO DAMAGED LINER. LINER AND CUP WERE REMOVED.

  Patient problems: Injury

  MAUDE report 7562941 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K960094. 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.
• Z-1066-2014 · Jan 23, 2014 · Terminated
  Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rh