SYNERGY 71306814Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010194688), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K211176, K240783, K963509); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING TOTAL HIP ARTHROPLASTY, AFTER USING SYNERGY TOOL OF NO. 14, THE POSITION AND STABILITY WAS SUITABLE. AFTER THAT, USING NO.14 STEM, THE INSTALLATION GAP IS 1.5 CM, AND IT COULD NOT BE IMPLANTED. AFTER 30 MINUTES, A NO. 13 STEM WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167623 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K240783, K963509. 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.