SYNERGY 71306613Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010194473), received between Nov 22, 2019 and Sep 21, 2021 — classified as 3 injuries.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT, AFTER A THR SURGERY, ONE SYN POR FEM COMP SZ 13, ONE R3 3 HOLE ACET SHELL 56MM, ONE OXINIUM FEM HD 12/14 36 MM -3, AND ONE R3 20 DEG XLPE ACET LNR 36MM X 56MM WERE ASSOCIATED WITH A POST-OPERATIVE REACTION (PAIN, INFECTION AND UNHEALED INCISION). THIS HAPPENED AFTER USE IN PATIENT. THE ISSUE WAS RESOLVED WITH A REVISION SURGERY, IN WHICH THE SURGEON REMOVED ALL THE IMPLANTS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Impaired Healing; Pain; Unspecified Infection

  MAUDE report 12510247 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT A MEDICALLY INDICATED INTERVENTION WAS PERFORMED ON (B)(6)2020 DUE TO TO NERVE PALSY OF THE SCIATIC NERVE. ON THE PROCEDURE IT WAS FOUND THAT THERE WAS A SIGNIFICANT AMOUNT OF SCAR AND ADHESIONS AROUND THE NERVE AT THE SCIATIC NERVE AREA. THE REPAIR WAS TAKEN DOWN AND THE ADHESIONS CAREFULLY FREED FROM THE NERVE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Nerve Damage

  MAUDE report 11593555 ↗
• InjuryNov 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REVISION DUE TO PAIN THAT BECAME PROGRESSIVELY WORSE. THE WHOLE SYSTEM WAS REPLACED.

  Patient problems: Pain

  MAUDE report 9362861 ↗