SYNERGY 71309012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010459671), received between Apr 26, 2021 and Apr 24, 2025 — classified as 4 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA REVISION SURGERY PERFORMED IN (B)(6) 2022, THE REVISION SURGERY FAILED DUE TO UNSPECIFIED REASONS. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, IT REMAIN UNKNOWN WHICH COMPONENTS WERE REVISED DURING THIS PROCEDURE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21898675 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NAME: LEFT THR WOUND INFECTION, STUDY ID: OR3O.2019.08, SUBJECT ID: 26-011, AE#: 1IT WAS REPORTED THAT DURING A CLINICAL STUDY, AFTER A THR PERFORMANCE ON FEB 18-2022, THE PATIENT EXPERIENCED A LEFT THR WOUND INFECTION. THE PATIENT UNDERGO A PERCUTANEOUS FINE NEEDLE ASPIRATION BIOPSY. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME IS RESOLVED AND IT WAS HOSPITALIZED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15875794 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL MDL. IT WAS REPORTED THAT THE PATIENT UNDERWENT MEDICALLY INDICATED REVISION OF THE BHR CUP AND THE COBALT-CHRONIUM MODULAR HEAD OF THE RIGHT HIP ON (B)(6) 2020. THE PATIENT REVISION SURGERY WAS PERFORMED DUE TO SEVERE PAIN, LIMITED MOBILITY, METALLOSIS, ELEVATED COBALT AND CHROMIUM LEVELS, AND ADVERSE LOCAL TISSUE REACTION. INTRA-OPERATIVE FINDINGS FROM THE REVISION SURGERY PERFORMED INDICATE LARGE FLUID COLLECTION IN HIP JOINT. THE STEM WAS ALSO REVISED DUE TO INADEQUATE STABILITY. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11849376 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT PRESENTED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REPLACE THE OXINIUM FEM HD 12/14 36MM -3, THE R3 20 DEG XLPE ACET LNR 36MM X 54MM AND THE SYN POR PLUS HA SO STEM SZ 12. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 11722572 ↗

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.