SYNERGY 71309113Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010459787), received between Feb 17, 2018 and Jul 2, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K002996, K090982, K211176); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY OF PRIMARY THR (B)(6) 2020. IT WAS INFORMED THAT THE PATIENT HAD ANOTHER REVISION SURGERY IN (B)(6) 2020, BECAUSE IT PRESENTED A PERIPROSTHETIC FRACTURING FEMUR. THE SURGEON REMOVED THE FEMORAL PROSTHESIS AND THE FEMORAL HEAD. ALSO, IT WAS KNOWN THAT THE STEM WAS SUBSIDED. THE SURGEON FIXED THE PROBLEM WITH THREE CABLES. THE SURGEON DID NOT BLAME THE DEVICES IN THE DEVELOPMENT OF THE PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 10224485 ↗
• InjuryMay 23, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY ON THE LEFT HIP WAS PERFORMED DUE TO PAIN ON MOVEMENT. AN XRAY SHOWED LYSIS AROUND THE FEMORAL STEM. THE SYN POR PLUS HA HO STEM SZ 13 WAS FOUND TO BE LOOSE AND WAS REMOVED. IT HAD VISIBLE SIGNS OF WEAR ON THE PROXIMAL SHOULDER. A REFLECTION LINER WAS ALSO REMOVED AND SHOWED SIGNS OF WEAR: SO A NEW LINER WAS IMPLANTED. THE OXINIUM HEAD WAS ALSO EXPLANTED BUT THERE IS NOT APPARENT FAILURE IN THE HEAD.

  Patient problems: Pain

  MAUDE report 10084646 ↗
• InjuryDec 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO LEG PAIN. THIS WAS TREATED VIA NERVE ROOT BLOCK (INJECTION).

  Patient problems: Pain

  MAUDE report 9446740 ↗
• InjuryNov 15, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE. THE FEMORAL HEAD AND THE STEM WERE EXPLANTED AND REPLACED. DELAY OF LESS THAN 30MIN REPORTED.

  Patient problems: Injury

  MAUDE report 8075427 ↗
• InjuryMay 9, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PERIPROSTHETIC FRACTURE.

  Patient problems: Injury

  MAUDE report 7500948 ↗
• InjuryFeb 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO THIGH PAIN AND THICKENING OF LATERAL FEMORAL CORTEX. THE LINER, THE STEM AND THE HEAD WERE REMOVED.

  Patient problems: Pain

  MAUDE report 7279469 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002996, K090982, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.