SYNERGY 71309013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010459688), received between Jun 5, 2020 and Dec 28, 2021 — classified as 2 injuries.

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

• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER LEFT BHR THA CONSTRUCT WAS IMPLANTED ON (B)(6) 2010, THE PLAINTIFF EXPERIENCED METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THE SURGERY, SIGNIFICANT OSTEOLYSIS WAS NOTED AROUND THE CUP, AS WELL AS LARGE COLLECTION OF BROWN FLUID. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 13100979 ↗
• InjuryJun 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A THR THE STEM WENT FURTHER THAN THE BROACH. SURGEON HAD TO GO UP TO A SIZE 15 SYNERGY FROM A 13. LES THAN 30 MINUTES DELAY REPORTED, AND A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10122972 ↗

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.