SYNERGY 71366514Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010199928), received between Sep 6, 2018 and Feb 28, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Corroded” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, THE MAGNET OF A SYN HO TRIAL NECK SZ 14-18 APPEARS TO BE PEELING AWAY. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624971 ↗
• MalfunctionFeb 28, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, THE MAGNET OF A SYN HO TRIAL NECK SZ 14-18 APPEARS TO BE PEELING AWAY. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624872 ↗
• MalfunctionFeb 28, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT THE MAGNETS ON THE DEVICE ARE CORRODED/CHIPPED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11390969 ↗
• MalfunctionFeb 26, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT, THE MAGNETS OF THE SYN HO TRIAL NECK SZ 14-18 ARE CORRODED, CHIPPED, AND FALLING OUT. INCIDENT OCCURRED DURING SERVICE; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386055 ↗
• MalfunctionFeb 25, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT, THE MAGNETS OF A SYN TRIAL NECK SZ 8-13 ((B)(4)) AND A SYN HO TRIAL NECK SZ 14-18 ((B)(4)) ARE CORRODED/CHIPPED/FALLING OUT. INCIDENT OCCURRED DURING SERVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376962 ↗
• MalfunctionFeb 25, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT, THE MAGNETS FROM THE SYN TRIAL NECK SZ 8-13 AND THE SYN HO TRIAL NECK SZ 14-18 ARE CORRODED/CHIPPED/FALLING OUT. INCIDENT OCCURRED DURING SERVICE/PM; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376951 ↗
• MalfunctionFeb 21, 2021Corroded; Fracture; Corroded; Fracture

  IT WAS REPORTED THAT THE MAGNETS ON THE SYNERGY TRIAL ARE CORRODED/FALLING OUT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356764 ↗
• InjurySep 6, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS REQUIRED DUE TO 16 BROACH (7136-6716, 14FM18758) SHRED OFF THE BROACH DURING HIP REPLACEMENT WITH HIGH OFFSET TRIAL NECK 7136-6514, 14GM06585. DR PERFORMED OSTEOTOMY TO REMOVE THE BROACH SUCCESSFULLY. THERE WAS 40 MINUTE DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852653 ↗

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