SYNERGY 71930715Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556050330), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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.

• MalfunctionMar 30, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING SURGERY, WHEN OPENING THE T THE SYNERGY PC FEM SZ16 120MM, IT WAS NOTICED THAT DEVICE CONTAINED IN THE BOX CORRESPONDED TO A SIZE 9 STANDARD OFFSET. PROCEDURE CONTINUED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW AND WITHOUT A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593101 ↗

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.