SYNERGY 71366508Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010199911), received between Jul 18, 2020 and Apr 29, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Corroded” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SYNERGY HO TRIAL NECK SIZE 8-13 BLACK COATING WHERE MAGNET IS COMING OFF . NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744161 ↗
• MalfunctionMar 8, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT DURING SERVICE/PM, MAGNET ON THE SYNERGY HIGH OFFSET TRIAL NECK SZ 8-13 WAS FOUND TO BE CHIPPED AND CORRODED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431113 ↗
• 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 11356766 ↗
• InjuryJul 18, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE WAS FOUND MISSING. THERE WAS A DELAY BELOW 30 MINUTES AND NO INJURY WAS REPORTED. NO BACKUP DEVICE WAS AVAILABLE AT THE MOMENT. THE SURGERY WAS FINISHED BY USING A STANDARD TRIAL STEM AND USING THE FINAL IMPLANT.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10293439 ↗

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