BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS 10CM SEG FM OSS TPR LT

    MDR report key: 6968167 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09504
    Event Type
    Injury
    Date Received
    October 23, 2017
    Date of Event
    October 25, 2016
    Report Date
    March 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK080330
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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). MEDICAL PRODUCTS - UNKNOWN OSS TIBIAL TRAY, UNKNOWN OSS BEARING. REPORT SOURCE: (B)(6). IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 178710 CPS TAPER LOCKING CAP / OSS SC 608540, 161039 OSS RS NON MOD PLATE LONG 67 755040, 178554 CPS SHORT ANCHOR PLUG 12MM 805180, 178363 CPS XS SHT SPDL W PINS 600LBF 389070, 178512 CPS NUT CO-CR-MO ALLOY 524860, 150476 OSS POLY TIBIAL BUSHING 036780, 178526 CPS TRANSVERSE PIN 6PK 28MM 524850, 178538 CPS TRANSVERSE PIN 6PK 28MM 524850, 178538 CPS CENTERING SLEEVE 16MM 324780, 150478 OSS POLY LOCK PIN 037040, 150477 OSS POLY FEMORAL BUSHINGS 2PK 232870, 150493 OSS REINFORCED YOKE 321890, 150480 OSS AXLE 807390. PRODUCT REMAINS IMPLANTED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAYS WERE SENT TO HCP FOR ADDITIONAL REVIEW, THEIR REVIEW NOTED A DISLODGED SCREW IN THE POSTERIOR JOINT RECESS. ALSO NOTED ON THE LATERAL VIEW IS PERIPROSTHETIC LUCENCY BETWEEN THE POSTERIOR TIBIAL PLATE AND THE BONE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO LOOSENING OF THE LAST FIXATION SCREW THROUGH THE FEMORAL BLOCK OF THE DISTAL FEMORAL RESECTION PROSTHESIS. THE SURGEON WAS CONCERNED THAT THE LOOSE SCREW WAS CAUSING BLOCKAGE OF THE KNEE JOINT AND COULD POSSIBLY DAMAGE THE METAL PROSTHETIC SURFACE AND ARTICULAR SURFACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST INITIAL KNEE SURGERY, THE PATIENT HAS A A BLOCKED KNEE JOINT DUE TO LOOSENING OF A LOCKING SCREW AT DISTAL FEMUR. 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
    748747 CPS 10CM SEG FM OSS TPR LT JDI ZIMMER BIOMET, INC. N/A 570740

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other