SYNERGY 71309114Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010459794), received between Jun 30, 2015 and Jun 30, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Compatibility 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2020Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT, AFTER AN R3-THA SURGERY HAD BEEN PERFORMED IN THE LEFT HIP, THE PATIENT EXPERIENCED PROSTHETIC JOINT INFECTION, FAILED LEFT HIP REPLACEMENT, PERONEAL NERVE PALSY RESULTING IN FOOTDROP, PERIPROSTHETIC FRACTURE AT THE LEVEL OF THE DISTAL ASPECT OF THE STUMP. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bacterial Infection; Hip Fracture

  MAUDE report 10216038 ↗
• InjurySep 18, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A REVISION SURGERY OF THE LEFT HIP WAS PERFORMED DUE TO A PERI PROSTHETIC FRACTURE OF THE PROXIMAL FEMUR. FEMORAL STEM, FEMORAL HEAD AND LINER WERE REMOVED AND REPLACED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6874628 ↗
• InjuryJun 30, 2015Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION WAS REPORTED DUE TO LOOSENING OF THE IMPLANT AND INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 4879306 ↗

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.