BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-CLAD POLY ACETABULAR CUP 28 MM

    MDR report key: 6059202 · Received October 26, 2016

    Report

    Report Number
    0001825034-2016-04279
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK926107
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 OR DEVIATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04279 AND 3002806535-2016-00801).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATE AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: STANMORE COCR FMRL SZ1 STD P/N 164241 L/N 5658585, 28 MM DIA COCR MOD HD - 6 MM NK P/N 163660 L/ N 0000033247. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE REPORTED CONDITION. REVIEW OF THE DEVICE HISTORY RECORD FOR SAME PART AND LOT IDENTIFIED NO DEVIATIONS OR ANOMALIES. COMPLAINT HISTORY REVIEW IDENTIFIED NO OTHER COMPLAINTS FOR THIS PART FOR THIS ISSUE. NO OTHER COMPLAINTS FOR SAME LO ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT 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 · 1

    PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY THIRTEEN YEARS POST-IMPLANTATION DUE TO LOOSENING OF THE ACETABULAR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708909 BIO-CLAD POLY ACETABULAR CUP 28 MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 781210

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R