SYNERGY 71306113Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010291974), received between Nov 5, 2018 and Nov 29, 2022 — classified as 3 injuries.

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

• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THIS WAS ADDRESSED ON (B)(6) 2019, TO EXCHANGE THE SYN POR HO FEM COM SZ 13, 40MM OXINIUM MODULAR HEAD, R3 20 DEG XLPE LNR 40MM ID X 60 OD AND TITANIUM MODULAR HEAD SLV 12/14 TPR +8 . IT IS UNKNOWN PATIENT'S CURRENT HEALTH STATUS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 15875790 ↗
• InjuryJul 26, 2022Fracture; Fracture

  BILATERAL PATIENT. IT WAS REPORTED THAT, FOLLOWING AN INITIAL LEFT R3-THA ON (B)(6) 2010, PLAINTIFF EXPERIENCED LEFT HIP PAIN AND POPPING EPISODES. PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2018, WHERE THE ACETABULUM WAS NOTED TO BE LOOSE WITH EROSION AND BROKEN SCREW HEADS. METALLOSIS, DEBRIS AND FLUID WERE OBSERVED. THE FEMORAL STEM WAS RETAINED. (COVER UNDER (B)(4)) ON (B)(6) 2022, PLAINTIFF EXPERIENCED LEFT HIP PAIN AND X-RAYS SHOWED HARDWARE FAILURE WITH FRACTURE THROUGH THE TAPER-NECK OF FEMORAL STEM RETAINED DURING THE 1ST REVISION SURGERY. PLAINTIFF UNDERWENT A 2ND REVISION SURGERY ON (B)(6) 2022, WHERE THE STEM WAS EXPLANTED. AN OSTEOTOMY REPAIR WITH KINAMED CABLE AND TROCHANTERIC 2-HOLE GRIP PLATE AND SCREWS WERE REQUIRED. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15104364 ↗
• InjuryNov 5, 2018High Test Results; High Test Results

  IT WAS REPORTED THAT PATIENT PRESENTS INCREASED TITANIUM LEVEL DUE TO TITANIUM IS PRESENT IN IMPLANTED COMPONENTS. TITANIUM LEVEL 3.64 (UPPER REFERENCE RANGE PER ALS (B)(4) AB IS 2.96).

  Patient problems: Patch Test, Abnormal Results Of; Test Result

  MAUDE report 8039622 ↗