BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A TPR HI CARBON LNR

    MDR report key: 7647968 · Received June 28, 2018

    Report

    Report Number
    0001825034-2018-04296
    Event Type
    Injury
    Date Received
    June 28, 2018
    Date of Event
    April 19, 2017
    Report Date
    August 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICE WAS RETURNED. X-RAYS AND MEDICAL RECORDS WERE REVIEWED AND CONFIRMED THE REPORTED EVENT. DEVICE HISTORY RECORD (DHR) REVIEW IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 9 YEARS POST INITIAL SURGERY DUE TO PAIN, LIMITED RANGE OF MOTION, METALLOSIS, PSEUDOTUMOR AND BONE EROSION. DURING THE SURGERY IT WAS FOUND THAT ANTERIOR CAPSULE HAD SIGNIFICANT METALLOSIS REACTION AND STAINING IN THE TISSUE. RADICAL RESECTION REMOVING THE ENTIRE ANTERIOR AND AS MUCH OF THE INFERIOR AND SUPERIOR CAPSULE. THERE WAS SIGNIFICANT METALLOSIS REACTION AROUND THE ACETABULAR IMPLANT WITH SIGNIFICANT SOFTENING AND BONE LOSS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: X11-180312, BI-METRIC/X POR NC LAT 12X140, 774930; 15-103684, M2A-T UNIV 2-HOLE SHL SZ 41/54, 801490; 11-163688, 32MM M2A HI CARBON HD STD NK, 767120. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04295; 0001825034 - 2018 - 04297; 0001825034 - 2018 - 04298. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S LEGAL COUNSEL THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO ELEVATED ION LEVELS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488736 M2A TPR HI CARBON LNR PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 912570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R