BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A HIP

    MDR report key: 3374400 · Received September 27, 2013

    Report

    Report Number
    0001825034-2013-04275
    Event Type
    Injury
    Date Received
    September 27, 2013
    Date of Event
    August 19, 2013
    Report Date
    October 9, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PRODUCT IDENTIFICATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - 11-173662, LOT NUMBER - 518320, EXPIRATION DATE - JUL 31, 2015, MANUFACTURE DATE ¿ JUL 13, 2005; CATEGORY NUMBER - 11-173662, LOT NUMBER - 911100, EXPIRATION DATE - DEC 31, 2016, MANUFACTURE DATE ¿ DEC 11, 2006; CATEGORY NUMBER - 11-173663, LOT NUMBER - 024510, EXPIRATION DATE - AUG 31, 2016, MANUFACTURE DATE ¿ AUG 7, 2006; CATEGORY NUMBER - 11-173661, LOT NUMBER - 995250, EXPIRATION DATE - JUL 31, 2016, MANUFACTURE DATE ¿ JUL 31, 2006; CATEGORY NUMBER - 15-105054, LOT NUMBER - 773380, EXPIRATION DATE - FEB 28, 2016, MANUFACTURE DATE ¿ FEB 16, 2006; CATEGORY NUMBER - 15-105056, LOT NUMBER - 980090, EXPIRATION DATE - AUG 31, 2016, MANUFACTURE DATE ¿ AUG 17, 2006; CATEGORY NUMBER - 15-105058, LOT NUMBER - 199670, EXPIRATION DATE - SEP 30, 2016, MANUFACTURE DATE ¿ OCT 2, 2006; CATEGORY NUMBER - 15-105048, LOT NUMBER - 351650, EXPIRATION DATE - JUL 31, 2015, MANUFACTURE DATE ¿ JUL 14, 2005. BIOMET IS IN RECEIPT OF 8 MISMATCHED EXPLANTS WITHOUT PATIENT IDENTIFICATION. BIOMET IS UNABLE TO ASSOCIATE SPECIFIC PATIENT WITH THIS REPORT. EXAMINATION OF RETURNED DEVICES FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOTS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489620 UNKNOWN M2A HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R