SYNERGY 71306614Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010194480), received between Feb 1, 2019 and May 20, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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.

• InjuryMay 20, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER PRIMARY LEFT HIP SURGERY WAS PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED ELEVATED METAL ION LEVELS, PAIN, MOBILITY PROBLEMS AND AN UNSPECIFIED PROBLEM IN THE ACETABULAR SHELL. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, THE PATIENT¿S SHELL, METALLIC LINER, METALLIC FEMORAL HEAD, AND MODULAR HEAD SLEEVE WERE EXPLANTED AND ONLY THE STEM WAS LEFT IN PLACE. THE HIP WAS REPLACED WITH A DIFFERENT THA SYSTEM. THE OUTCOME OF THE PATIENT AFTER THE REVISION WAS GOOD.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14455254 ↗
• InjuryNov 4, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED, THAT A PATIENT WAS HOSPITALIZED DUE TO NON-UNION OF LEFT FEMORAL NECK FRACTURE AFTER A SYNERGY POROUS-COATED STEM SZ 14 HAD BEEN IMPLANTED AND PLANNED TO UNDERGO THROUGH A TOTAL HIP ARTHROPLASTY. THE PATIENT HAD A LARGE ANTERIOR FEMORAL ARCH, AND THE SYNERGY POROUS-COATED STEM SZ 14 WAS SLIGHTLY EVERTED AFTER SURGERY. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12750874 ↗
• InjuryFeb 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO AN INFECTION. THE ONLY S&N DEVICE EXPLANTED IS THE FEMORAL STEM. NO DELAY OR ADDITIONAL INJURIES REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 8299083 ↗