BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER STANDARD NECK

    MDR report key: 5999492 · Received October 5, 2016

    Report

    Report Number
    0001825034-2016-03955
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    November 9, 2015
    Report Date
    January 28, 2021
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AN M2A 38MM MOD HD STD NK, PART # 11-173662 FROM LOT 429160, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE OUTER RADIUS TO BE SCUFFED AND WORN. THE RIM OF THE HEAD IS SCRATCHED AND DINGED. BLACK DEBRIS WAS OBSERVED INSIDE THE TAPER. ADDITIONAL INFORMATION PROVIDED DOES NOT CHANGE THE ROOT CAUSE OF THE PREVIOUS INVESTIGATION. 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 · 1

    (B)(4). MEDICAL PRODUCTS - M2A ACETABULAR CUP CATALOG#: RD118856 LOT#: 473940, MALLORY FEMORAL STEM CATALOG#: 11-104212 LOT#: 213430. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-03955 & 2017-01613).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REVIEW OF THE PROVIDE OP NOTES CONFIRMED THE COMPLAINT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT HIP REVISION PROCEDURE APPROXIMATELY ELEVEN YEARS POST-IMPLANTATION DUE TO UNSPECIFIED ALLEGATIONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT HIP REVISION PROCEDURE APPROXIMATELY ELEVEN YEARS POST-IMPLANTATION DUE TO UNSPECIFIED ALLEGATIONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. IT WAS REPORTED IN MEDICAL RECORDS RECEIVED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY ELEVEN YEARS POST-IMPLANTATION DUE TO PAIN, ELEVATED METAL ION LEVELS AND A RETROVERTED ACETABULAR COMPONENT. DURING THE PROCEDURE, METALLOSIS AND METAL STAINING WERE NOTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652663 M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER STANDARD NECK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 429160

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R