BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 8612570 · Received May 15, 2019

    Report

    Report Number
    0001825034-2019-02186
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    April 13, 2019
    Report Date
    January 31, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, G4, G7, H2, H3, H6, AND H10. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE SCREW IS FRACTURED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02183, 0001825034-2019-02184, 0001825034-2019-02185. CONCOMITANT MEDICAL PRODUCTS: MOD ARTHRO NL 3CM DIASL CNCTR CATALOG#: CP260607 LOT#: NI, MOD ARTHRO 0 DEG LCK COLLAR CATALOG#: CP260600 LOT#: 341290, OSS SEGMENTAL STACKING ADAPTER CATALOG# 150483 LOT#: 302180, CPS LG SPDL WITH PINS 800LBF CATALOG#: 178358 LOT#: 502600, CPS LG SPDL WITH PINS 800LBF CATALOG#: 178404 LOT#: 213070, CPS TRANSVERSE PIN 6PK 32MM CATALOG#: 178527 LOT#: 134880, CPS CENTERING SLEEVE 18MM CATALOG#: 178540 LOT#: 131070, CPS NUT CO-CR-MO ALLOY CATALOG#: 178512 LOT#: 498690, CPS ANCHOR PLUG 10MM CATALOG#: 178400 LOT#: 182490, CPS SM SPDL WITH PINS 800LBF CATALOG#: 178355 LOT#: 717020, CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG#: 178711 LOT#: 433100, CPS NUT CO-CR-MO ALLOY CATALOG#: 178512 LOT#: 222820, CPS TRANSVERSE PIN 6PK 32MM CATALOG#: 178527 LOT#: 742300, CPS CENTERING SLEEVE 15MM CATALOG#: 178537 LOT#: 935290, CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG#: 178711 LOT#: 250750, MOD ARTHRO NL 3CM DIASL CNCTR CATALOG#: CP260607 LOT#: 580090, OSS 4CM DIAPHYSEAL SEGMENT CATALOG#: 150482 LOT#: 801580, OSS SEGMENTAL STACKING ADAPTER CATALOG#: 150483 LOT#: 580530, MOD ARTHRO 0 DEG LCK COLLAR CATALOG#: CP260600 LOT#: 491090, MOD ARTHRO NL 3CM DIASL CNCTR CATALOG#: CP260607 LOT#: 181570. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, UNDERWENT A REVISION DUE THE IMPLANT FRACTURED WHILE WALKING FOUR (4) YEAR FIVE (5) MONTHS POST PRIMARY IMPLANTATION. PATIENT WAS WALKING FIVE MILE PER DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405499 UNKNOWN SCREW PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R SEE H10