REFLECTION 71336458Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010454386), received between Dec 11, 2017 and Dec 28, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionDec 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REF XLPE 32 20 DEG 58-60 G COULD NOT BE INSTALLED WITH A REF THREE HOLE SHELL 58MM, ALTHOUGH IT WAS TRIED FOR AN HOUR IN VARIOUS DIRECTIONS. SURGERY WAS COMPLETED, AFTER A DELAY OF AN HOUR, WITH A S+N BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095858 ↗
• InjuryOct 23, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING THA SURGERY, THE LINER CAN'T BE PLACED SMOOTHLY AFTER THE SURGEON IMPLANTED THE REFLECTION ACETABULAR SYSTEM. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO HARM OR INJURY REPORTED ON PATIENT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 10729960 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGERY WAS SCHEDULE FOR A PATIENT AFTER A PET SCAN WAS PERFORMED. CLINICAL ANALYSIS INDICATED AN INFECTION WAS PRESENT. THE DECISION WAS MADE TO REMOVE THE CUP AND LINER AS WELL AS THE FEMORAL HEAD. THE NEW IMPLANTS WERE FROM A COMPETITOR, HOWEVER A S&N FEMORAL HEAD (36MM +12) WAS IMPLANTED. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10439571 ↗
• InjuryDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE ALL THE PARTS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7105147 ↗

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