BEUDAMED
    FDA Adverse Event Death Summary report: N

    BONE SCR 6.5X20 SELF-TAP

    MDR report key: 6736575 · Received July 24, 2017

    Report

    Report Number
    0002648920-2017-00472
    Event Type
    Death
    Date Received
    July 24, 2017
    Date of Event
    May 15, 2016
    Report Date
    December 11, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MRA
    PMA / PMN Number
    PK934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS (B)(4). IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4) AVENIR® MüLLER, STEM, (B)(4); (B)(4) TRABECULAR METAL¿¢ ACETABULAR REVISION SYSTEM, BUTTRESS AUGMENT (B)(4); (B)(4) TRABECULAR METAL ¿¢ ACETABULAR REVISION SYSTEM, COLUMN BUTTRESS, (B)(4); (B)(4) TRABECULAR METAL¿¢ ACETABULAR REVISION SYSTEM, COLUMN BUTTRESS, (B)(4); (B)(4) SHELL WITH MULTI HOLES POROUS (B)(4); (B)(4) FEMORAL HEAD PRODUCT (B)(4); (B)(4) CONSTRAINED LINER WITH RING (B)(4); (B)(4) BONE SCREW (B)(4); (B)(4) BONE SCREW (B)(4); (B)(4) BONE SCREW (B)(4); (B)(4) BONE SCREW (B)(4); (B)(4) BONE SCREW (B)(4); (B)(4) BONE SCREW (B)(4); (B)(4) BONE SCREW (B)(4); (B)(4) BONE SCREW (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-05117, 0002648920-2017-00470, 0001822565-2017-05118, 00002648920-2017-00471, 0002648920-2017-00472, 0002648920-2017-00473, 0002648920-2017-00474, 0002648920-2017-00475, 0002648920-2017-00476, 0002648920-2017-00477 & 0002648920-2017-00478.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS IDENTIFIED AN INTERNAL SOFTWARE ERROR PRODUCED AND SUBMITTED AN INVALID D2 DEVICE PRODUCT CODE IN THE PREVIOUS SUBMISSIONS RELATED TO THIS REPORTING. THE DEVICE PRODUCT CODE HAS BEEN UPDATED WITH NO FURTHER CHANGES. 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 INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. DHR INDICATES THE DEVICE WAS STERILIZED TO SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL COUNSEL THAT THE PATIENT DIED APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO RESPIRATORY FAILURE RELATED TO CHONDROSARCOMA. THE PROXIMATE CAUSE OF HER DEATH WAS INFECTION AND NECROSIS FROM NEGLIGENCE DURING AND AFTER SURGERY.

    Description of Event or Problem · 1

    NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL COUNSEL THAT THE PATIENT DIED APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO RESPIRATORY FAILURE RELATED TO CHONDROSARCOMA. THE PROXIMATE CAUSE OF HER DEATH WAS INFECTION AND NECROSIS, TREATED WITH AMPUTATION, FROM NEGLIGENCE DURING AND AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515635 BONE SCR 6.5X20 SELF-TAP PROSTHESIS, HIP MRA ZIMMER MANUFACTURING B.V. N/A 62640321

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death