SYNERGY 71306616Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010194503), received between Mar 1, 2021 and Feb 15, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A MOM-THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2004, THE NECK OF THE SYNERGY POROUS FEMORAL COMPONENT SZ 16 FRACTURED. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16379307 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT HIP BHR-THA REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2020 FOLLOWING A METALLOSIS AND FAILED TOTAL HIP ARTHROPLASTY DIAGNOSIS ((B)(4)), THE PATIENT EXPERIENCED A CHRONIC AND RECALCITRANT PROSTHETIC JOINT INFECTION. DESPITE MULTIPLE OPERATIONS TO ADDRESS THE INFECTION IN WHICH AN ANTIBIOTIC SPACER WAS PLACED, A RESECTION ARTHROPLASTY WAS CONDUCTED ON (B)(6) 2021 TO FURTHER TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE ACETABULAR LINER AND THE FEMORAL STEM WERE EXPLANTED AND A COPIOUS SALINE IRRIGATION WITH EXCISIONAL DEBRIDEMENT ON BONY SURFACES WAS PERFORMED. INTRAOPERATIVELY, SIGNIFICANT DEBRIS AND APPARENT HEMATOMA OR INFECTION WAS EVIDENT. SERIAL SEQUENTIAL WASHES WERE PERFORMED ON THE DEBRIDED SURFACES, WITH A SUBSEQUENT PLACEMENT OF STIMULANT BEADS INCLUDING VANCOMYCIN AND LIQUID TOBRAMYCIN. THE ARTHROTOMY, FASCIA AND SKIN WERE CLOSED, UNTIL FURTHER EVALUATION OF THE CLINICAL COURSE OF THE PATIENT WAS OBTAINED TO PERFORM A DEFINITIVE RECONSTRUCTION. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN ((B)(4)).

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 14570567 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 3 MOTHS AFTER A LEFT REVISION SURGERY PERFORMED IN (B)(6) 2015 (CAPTURED UNDER (B)(4)), THE PATIENT EXPERIENCED PAIN ON THE AREA. THE PHYSICIAN DIAGNOSED TRAUMATIC BURSITIS, WHICH WAS TREATED WITH SOME PHYSICAL THERAPY AND ULTRASOUND TREATMENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation; Pain

  MAUDE report 11949395 ↗
• InjuryMar 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT FELL AND FRACTURED FEMUR. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021 TO ADDRESS THE ADVERSE EVENT. THE SYNERGY POR FEM COMP SZ 16 WAS REMOVED AND REPLACED WITH OSS LIMB SALVAGE PROXIMAL FEMUR. THE PATIENT ALSO HAD A CERAMIC LINER THAT WAS REMOVED AND REPLACED WITH OR3O. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Hip Fracture

  MAUDE report 11391123 ↗