BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS SEGMENTAL ANCHOR PLUG 14MM W/DRILL SET AND W/PIN INSERTER

    MDR report key: 6107791 · Received November 16, 2016

    Report

    Report Number
    0001825034-2016-04710
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 17, 2016
    Report Date
    March 24, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK043547
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 7 STATES, FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT. NUMBER 12 STATES, INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR INTRAOPERATIVE PAIN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: POSTERIOR STABILIZING OSS SALVAGE 5CM TAPER ADAPTOR CATALOG #: 178711 LOT#: 790370. OSS SALVAGE 7CM SEGMENTAL FEMOR LEFT CATALOG #: 150355 LOT #: 171270. COMPRESSION NUT CATALOG #: 178512 LOT#: 825280. COMPRESS 1CM SPINDLE CATALOG #: 178472, LOT#: 868590. OSS POLY LOCK PIN CATALOG #: 150478 LOT#: 854880. RHK BEARING CATALOG #: 159430 LOT #: 3809596. COMPRESS LARGE SPINDLE CATALOG #: 178508 LOT #: 314790. RHK SEGMENTAL SHORT YOKE CATALOG #: 161571 LOT #: 3560459. OSS AXLE CATALOG #: 150480 LOT #: 371380, RHK TIBIAL BUSH CATALOG #: 154973 LOT #: 3763662. OSS POLY FEMORAL BUSHING CATALOG #: 150477 LOT #: 950400. OSS POLY LOCK PIN CATALOG #: 150478 LOT #: 761760. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SENT TO RELAY ADDITIONAL INFORMATION THAT WAS RECEIVED FROM THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A KNEE REVISION DUE TO IMPLANT FRACTURE AND PERIPROSTHETIC FRACTURE APPROXIMATELY TWO MONTHS POST IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO PERIPROSTHETIC AND IMPLANT FRACTURE. ADDITIONALLY IT WAS NOT CONFIRMED THAT A FALL HAD TAKEN PLACE BUT BELIEVED THAT THE PATIENT HAD STUMBLED AT THE TIME OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756711 COMPRESS SEGMENTAL ANCHOR PLUG 14MM W/DRILL SET AND W/PIN INSERTER PROSTHESIS, KNEE KWA BIOMET ORTHOPEDICS N/A 823160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R