REFLECTION 71333335Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010455680), received between Sep 7, 2018 and Apr 2, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A BIO THR SURGERY, THE REF XLPE 32 20 DEG 54-56 F COULDN'T BE IMPLANTED INTO THE CUP AFTER TRYING SEVERAL TIMES. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610551 ↗
• MalfunctionDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, THE REFLECTION LINER COULDN'T BE IMPLANTED INTO THE CUP. FINALLY A R3 LINER AND CUP WERE USED TO COMPLETE THE SURGERY. NO INJURY OR IMPACT TO PATIENT REPORTED. DELAY OF 1 HOUR REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9480950 ↗
• InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  US LEGAL; IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL THE COMPONENTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9349940 ↗
• MalfunctionFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER CONTINUOUSLY CAN'T BE IMPLANTED INTO THE OUTER CUP. DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8307888 ↗
• MalfunctionFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER CONTINUOUSLY CAN'T BE IMPLANTED INTO THE OUTER CUP. DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8305368 ↗
• MalfunctionSep 7, 2018Material Too Rigid or Stiff; Fitting Problem

  IT WAS REPORTED THAT THE DOCTOR IMPLANTED THE REF CUP DURING THE OPERATION THEN OPENED THE INSERT WHILE IT COULDN'T GET INTO THE CUP. UNDER THE CONDITION THAT THE PRODUCT CODE WAS CONSISTENT WITH THE OUTER CUP, IT WAS ALWAYS NOT IN PLACE. THE STAFF TEMPORARILY TOOK A NEW SET OF PRODUCTS, BUT IT WAS STILL CAN NOT BE IMPLANTED. THE DOCTOR TRIED TO TAKE THE PRODUCT OUT OF THE BODY, AND THE INSERT AND THE CUP WERE NOT IN PLACE OUTSIDE THE BODY. FINALLY A NEW OUTER CUP WAS OPENED AND THE INSERT WAS RIGIDLY IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7855516 ↗

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.