SYNERGY 71316211Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010410573), received between Nov 2, 2017 and Dec 24, 2019 — classified as 1 injury, 1 malfunction.

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

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

• MalfunctionDec 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A THR PROCEDURE, AN EXPIRED IMPLANT WAS OPENED AND CEMENTED IN PLACE. BY THE TIME IT WAS REALIZED, IT WAS TOO LATE TO USE A NEW IMPLANT. THERE WERE NO DELAYS IN THE PROCEDURE AND NO PATIENT INJURIES REPORTED. THERE IS NO MEDICAL OR SURGICAL INTERVENTION PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9517211 ↗
• InjuryNov 2, 2017Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD PROGRESSIVE TIGHT PAIN, AND THAT X-RAYS WERE CONSISTENT WITH FEMORAL COMPONENT LOOSENING SHOWING LUCENCY AROUND FEMORAL COMPONENT WITH SLIGHT VARUS MIGRATION OF THE FEMORAL STEM. FEMORAL STEM AND FEMORAL HEAD WERE REVISED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 6995648 ↗

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.