SYNERGY 71316014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010410535), received between May 30, 2022 and May 30, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K211176, K990369); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HEMI-ARTHROPLASTY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED HIP INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REVISE TO TOTAL; HOWEVER, DURING THE SURGERY IT WAS FOUND THAT THE SYN CEM FEM COMP SZ 14 WAS LOOSE AND PULLED OUT WITH EASE. ALSO, IT WAS FOUND THAT THERE WAS A POSSIBLE PATIENT INFECTION, AND THAT NO BONE CEMENT WAS BONDED TO STEM. THE PATIENT IS CURRENTLY ON THE FIRST STAGE OF A TWO-STAGES REVISION SURGERY, FOR WHICH A CEMENT SPACER IS BEING USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 14539254 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K990369. 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.