SYNERGY 71309011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010459664), received between Jul 13, 2017 and Sep 17, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT HIP BIPOLAR ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2007, THE PATIENT EXPERIENCED PAIN AND EROSIVE CHANGES OF THE ACETABULUM. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2018. TWO COMPONENTS WERE EXCHANGED: COCR 12/14 FEM HEAD 28 +0 (B)(4) AND TANDEM BIPOLAR COCR 46OD 28ID (B)(4), WHILE THE SYN POR PLUS HA SO STEM SZ 11 WAS RETAINED, RESULTING IN A CONVERSION TO A TOTAL HIP ARTHROPLASTY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Erosion; Failure of Implant; Injury; Pain

  MAUDE report 10551816 ↗
• InjuryJul 13, 2017Use of Device Problem; Fracture; Loose or Intermittent Connection; Use of Device Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE. THE SURGEON'S FIRST CHOICE WAS A CABLE BECAUSE OF THE PATIENTS AGE. STEM WAS NOTICED TO BE LOOSE BECAUSE OF THE FRACTURE.

  Patient problems: Hip Fracture; No Code Available

  MAUDE report 6709789 ↗

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.