BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS RS 7 CM MOD SEG FMRL-RT

    MDR report key: 7374405 · Received March 27, 2018

    Report

    Report Number
    0001825034-2018-02241
    Event Type
    Injury
    Date Received
    March 27, 2018
    Date of Event
    February 6, 2018
    Report Date
    March 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK051479
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT MEDICAL PRODUCTS: CPS SHORT ANCHOR PLUG 12MM CATALOG # 178554 LOT # 492760. CPS TRANSVERSE PIN 6PK 28MM CATALOG # 178526 LOT # 039180. OSS NON-MOD TIB PLATE LONG 67 CATALOG # 150420 LOT # 387620. CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG # 178711 LOT # 219590. CPS NUT CO-CR-MO ALLOY CATALOG # 178512 LOT # 279460. OSS SEGMENTAL STACKING ADAPTER CATALOG # 150483 LOT # 426580. OSS REINFORCED YOKE CATALOG # 150493 LOT # 638850. OSS POLY LOCK PIN CATALOG # 150478 LOT # 769960. OSS POLY TIBIAL BUSHING CATALOG # 150476LOT # 790090. OSS RS AXLE CATALOG # 161035 LOT # 011840. OSS RS POLY FEM BUSHINGS SET/2 CATALOG # 161034 LOT # 530630. OSS SEGMENTAL STACKING ADAPTER CATALOG # 150483 LOT # 011870. OSS TIBIAL POLY BEARING 12MM CATALOG # 150410 LOT # 710690. CPS SHRT 600# SM SPINDLE HA CATALOG # 178576 LOT # 123420. CPS CENTERING SLEEVE 14MM CATALOG # 178536 LOT # 739380. OSS 4CM DIAPHYSEAL SEGMENT CATALOG # 150482 LOT # 906220. SERIES A PAT THN 34 3 PEG CATALOG # 184786 LOT # 025000. OSS RS 7 CM MOD SEG FMRL-RT CATALOG # 161011 LOT # 183220. OSS RS POLY FEM BUSHINGS SET/2 CATALOG # 161034 LOT # 225940. TRABECULAR METAL¿¢ CONE FULL CATALOG # 00545006701 LOT # 61534128. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAYS PROVIDED WERE SENT TO HCP FOR ADDITIONAL REVIEW. IT WAS NOTED THERE IS A ROUNDED OPACITY ALONG THE ARTICULAR SURFACE OF THE DISTAL FEMUR ANTERIORLY WITHIN THE JOINT SPACE WHICH SUGGESTS POSSIBLE HARDWARE DISASSEMBLY. THE ADDITIONAL REVIEW IDENTIFIED RADIOLUCENCY ALONG THE PROXIMAL TIBIA AT THE BONE CEMENT IN THE CEMENT HARDWARE INTERFACES POSTERIORLY. MORE PROMINENT RADIOLUCENCY WAS NOTED ANTERIORLY WITHIN THE PROXIMAL TIBIA WHICH COULD SUGGEST OSTEOLYSIS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. WITH THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE FOR THE BACKING OF THE SCREW CANNOT BE DETERMINED. 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 THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED AS THE SCREW BACKED OUT OF DISTAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219154 OSS RS 7 CM MOD SEG FMRL-RT KNEE PROSTHESSIS KRO ZIMMER BIOMET, INC. N/A 183220

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R