SYNERGY 71306612Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010194466), received between Aug 13, 2018 and Apr 29, 2022 — classified as 4 injuries.

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

• InjuryApr 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED LOOSENING OF THE STEM. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6)2022 TO EXCHANGE THE SYN POR FEM COMP SZ 12. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14247456 ↗
• InjuryJun 16, 2019Fracture; Fracture

  IT WAS PERFORMED THAT REVISION SURGERY WAS PERFORMED TO FIX FEMORAL FRACTURE CAUSED BY FALLING DOWN. THE SURGEON DOES NOT BLAME THE PRODUCT BECAUSE THE PATIENT HAS DEMENTIA.

  Patient problems: Injury

  MAUDE report 8702578 ↗
• InjuryDec 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PATIENT LI.XI. SUFFERED A DISLOCATION SEVEN WEEKS AFTER HER HIP REPLACEMENT.

  Patient problems: Joint Dislocation

  MAUDE report 8124809 ↗
• InjuryAug 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY. ORIGINAL HIP REPLACEMENT WAS IN 1999 BY DR (B)(6). THE PATIENT HAD A REVISION OF LINER & HEAD IN (B)(6) 2018 DUE TO DISLOCATION & POSSIBLE INFECTION. SYNERGY SIZE 12 STEM REMOVED & 64MM OD MULTI HOLE CUP & LINER REMOVED WITH A CERAMIC SIZE 36 HEAD.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7776802 ↗