BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOMET HIP SYSTEM

    MDR report key: 24664455 · Received March 23, 2026

    Report

    Report Number
    0001825034-2026-00677
    Event Type
    Death
    Date Received
    March 23, 2026
    Date of Event
    January 12, 2022
    Report Date
    May 11, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868308277
    PMA / PMN Number
    K990830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B7; D4; G2; G3; H2; H4; H6; H10. THE FOLLOWING SECTIONS WERE CORRECTED: E1 CONTACT; E2; E3. PERIOPERATIVE STROKE IS DEFINED AS A BRAIN INFARCTION OF ISCHEMIC OR HEMORRHAGIC ETIOLOGY THAT OCCURS DURING SURGERY OR WITHIN 30 DAYS AFTER SURGERY. THE GREATEST RISK FACTORS FOR POSTOPERATIVE STROKE INCLUDE A HISTORY OF STROKE, INCLUDING TRANSIENT ISCHEMIC ATTACK, ADVANCED AGE, ANEMIA (HEMATOCRIT <27%), AND RENAL DYSFUNCTION. MOST PERIOPERATIVE STROKES OCCUR ON POSTOPERATIVE DAYS 2¿9. SURGERIES THAT ARE AT PARTICULARLY HIGH RISK INCLUDE EMERGENCY SURGERY, VASCULAR SURGERY (SUCH AS CAROTID ENDARTERECTOMY AND THORACIC ENDOVASCULAR AORTIC REPAIR), AND BRAIN SURGERY. SINCE MOST PERIOPERATIVE STROKES IN NONCARDIAC, NON-NEUROLOGICAL SURGERY ARE ISCHEMIC IN NATURE, THEY ARE TYPICALLY ATTRIBUTED TO HYPOTENSION AND/OR LOW-FLOW STATES, PREVIOUSLY UNDISCLOSED LARGE-ARTERY STENOSIS, ANEMIA-ASSOCIATED TISSUE HYPOXIA, EMBOLISM (THROMBUS, FAT, OR FOREIGN MATERIAL), ENHANCED COAGULABILITY OR THROMBOSIS IN THE SETTING OF SYSTEMIC INFLAMMATION, AND/OR RECENT DISCONTINUATION OF ANTITHROMBOTIC MEDICATIONS. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW WILL NOT BE COMPLETED. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 650-0327 LOT# UNK TPRLOC COCR CMTD STM T1 12.5MM. G2: FOREIGN ¿ EVENT OCCURRED IN THE NETHERLANDS. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST HIP IMPLANTATION, THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT AND PASSED AWAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331709 BIOMET HIP SYSTEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 246360 00887868308277

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Death