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SYNERGY 71366710Recalls & reported problems

Smith & Nephew, Inc. · SYNERGY FULLY TOOTHED BROACH SIZE 10 · Class 2

All models of SYNERGY (52)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010429636), received between Sep 27, 2020 and Oct 7, 2020 — classified as 2 malfunctions.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Connection Problem1
  • Defective Device1
  • Fitting Problem1
  • Incomplete or Inadequate Connection1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 7, 2020Defective Device; Defective Device

    IT WAS REPORTED THAT SURGEON DOES NOT LIKE HOW THE BROACHES ARE SEATING. NO CASE RELATED, THEREFORE NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Patient Involvement

    MAUDE report 10645714 ↗
  • MalfunctionSep 27, 2020Fitting Problem; Connection Problem; Incomplete or Inadequate Connection; Fitting Problem; Connection Problem; Incomplete or Inadequate Connection

    IT WAS REPORTED THAT THE BROACHES WERE NOT SEATING PROPERLY. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO PATIENT INJURIES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10591329 ↗

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 and updates

How reports and recalls are matched · Editorial policy · Report an error on this page