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REFLECTION 71363658Recalls & reported problems

Smith & Nephew, Inc. · TRIAL LINER 20 DEGREE 36MM 58-60 G · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010479839), received between Sep 1, 2021 and Sep 5, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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

Device problems

  • Break4
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 5, 2022Fracture; Fracture

    IT WAS REPORTED THAT, DURING A THR, (2) TRIAL 20 DEG 36MM 58-60G CENTER SCREWS BROKE. THE SURGERY WAS COMPLETED WITH THE SAME DEVICE. NO INJURIES OR DELAYS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15358685 ↗
  • InjuryFeb 22, 2022Break; Break

    IT WAS REPORTED THAT DURING THR, THE TRIAL 20 DEG 36MM 58-60 G BROKE DURING INSERTION, AND IT WAS RECOVERED WITH FORCEPS. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13577891 ↗
  • MalfunctionOct 27, 2021Break; Break

    IT WAS REPORTED THAT A TRIAL 20 DEG 36MM 58-60 G WAS FOUND BROKEN. IT IS UNKNOWN WHEN THIS HAPPENED OR IF THERE WAS A PATIENT INVOLVED. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12705873 ↗
  • MalfunctionSep 2, 2021Break; Break

    IT WAS REPORTED DURING A THR THAT (1) TRIAL 20 DEG ANT+4 36 58-60 G AND (1) TRIAL 20 DEG 36MM 58-60 G BOTH BROKE WHILE BEING SCREWED INTO APEX HOLE OF CUPS. THIS FAILURE LED TO A CHANGE IN THE SURGICAL TECHNIQUE, NO DELAY REPORTED. NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12418452 ↗
  • MalfunctionSep 1, 2021Break; Break

    IT WAS REPORTED THAT TWO (2) TRIALS, A TRIAL 20 DEG ANT+4 36 58-60 G AND A TRIAL 20 DEG 36MM 58-60 G ARE BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12408125 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

  • Z-0730-2019 · Jan 7, 2019 · Terminated
    SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
  • Z-1008-2017 · Nov 16, 2016 · Terminated
    REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116

Other Prosthesis, hip, femoral component, cemented, metal devices

All Prosthesis, hip, femoral component, cemented, metal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.