BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD ARTHRO 0 DEG LCK COLLAR

    MDR report key: 8612566 · Received May 15, 2019

    Report

    Report Number
    0001825034-2019-02184
    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
    HSB
    PMA / PMN Number
    K042049
    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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS PRODUCT WAS REPORTED IN ERROR AND DID NOT CONTRIBUTED TO THE REPORTED EVENT. THE INITIAL REPORT SUBMITTED NEEDS TO BE VOIDED.

    Description of Event or Problem · 0

    FOLLOWING INVESTIGATION, IMPLANT WAS DETERMINED TO NOT BE SUBJECT OF COMPLAINT.

    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, 0001825034-2019-02185, AND 0001825034-2019-02186. UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: MOD ARTHRO NL 3CM DIASL CNCTR, CATALOG#: CP260607, LOT#: NI. OSS SEGMENTAL STACKING ADAPTER, CATALOG# 150483, LOT#: 302180. UNKNOWN SCREW, CATALOG#: NI, LOT#: NI. 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
    405289 MOD ARTHRO 0 DEG LCK COLLAR PLATE, FIXATION HSB ZIMMER BIOMET, INC. N/A 341290

    Patients

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