BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD COMPONENT 32 MM HEAD DIAMETER/ NO SKIRT PLUS 6 MM NECK TYPE I TAPER

    MDR report key: 6743948 · Received July 26, 2017

    Report

    Report Number
    0001825034-2017-05146
    Event Type
    Injury
    Date Received
    July 26, 2017
    Date of Event
    March 24, 2017
    Report Date
    April 4, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK974558
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCTS: 010000851 3690352 G7 NEUTRAL E1 LINER 32 MM G, 192112 293090 BI-METRIC ECHO PC LAT 12 X 140, 010000667 3891229 G7 PPS LTD ACETABULAR SHL 60G. (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05147.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE REPORTS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05146, 0001825034-2017-05147, 0001825034-2018-02237.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED COMPLICATION OF LUXATION APPROXIMATELY 3 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED COMPLICATION OF LUXATION APPROXIMATELY 3 MONTHS POST-IMPLANTATION. NO HOSPITALIZATION WAS REQUIRED AS THE HIP WAS REPORTED TO HAVE REDUCED WITHOUT INTERVENTION AS THE PATIENT MOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED COMPLICATIONS OF LUXATION APPROXIMATELY 3 MONTHS POST-IMPLANTATION. THE PATIENT EXHIBITS SOME TENDERNESS IN THE AREA, NOTED A 0.5 CM SHORTER LEG LENGTH DIFFERENCE, AND A 0.5 CM SUBSIDENCE OF THE STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526222 MODULAR HEAD COMPONENT 32 MM HEAD DIAMETER/ NO SKIRT PLUS 6 MM NECK TYPE I TAPER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 746610

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other