BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 38 MM HEAD DIAMETER MINUS 6 MM NECK

    MDR report key: 6376159 · Received March 3, 2017

    Report

    Report Number
    0001825034-2017-01217
    Event Type
    Injury
    Date Received
    March 3, 2017
    Date of Event
    October 10, 2007
    Report Date
    April 16, 2021
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FINDINGS: MARKED SYNOVITIS W/ NECROTIC DEBRIS WITHIN THE JOINT. CLOUDY FLUID WITHIN JOINT, CULTURES SHOW NO EVIDENCE OF ACUTE INFLAMMATION ACETABULAR COMPONENT FOUND TO BE WELL FIXED, BUT ABLE TO BE REMOVED 36 CERAMIC HEAD, 3 NECK LENGTH, AND AN E-POLY SIZE 24 LINER WITH 36 HEAD SIZE AND A 56 LIMITED HOLE RANAWAT ACETABULAR COMPONENT WITH 2 DOME SCREWS PLACED. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME 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

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. CONCOMITANT PRODUCTS- PART: RD118850 NAME: M2A-38 CUP 50MM LOT: 292682; PART: 162610 NAME: POR INTGL RDCD PRX PRF 9X125 LOT: 646550. MULTIPLE MDRS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-01211.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE INITIAL NOTIFICATION DATE IS BEING CORRECTED TO JAN 30, 2017.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO PAIN. HEAD AND CUP WERE REMOVED. IT WAS NOTED THAT THERE WERE SIGNS OF SYNOVITIS WITH NECROTIC DEBRIS. DURING SURGERY THERE WAS CLOUDY FLUID AND GRAYISH EXUDATE THROUGHOUT THE JOINT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED APPROXIMATELY 4 YEARS POST-IMPLANTATION DUE TO AN UNKNOWN REASON. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159070 M2A MODULAR HEAD COMPONENT 38 MM HEAD DIAMETER MINUS 6 MM NECK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 000310

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R