BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS DIAPHYSEL SEGMENT

    MDR report key: 7291724 · Received February 23, 2018

    Report

    Report Number
    0001825034-2018-01048
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    February 6, 2018
    Report Date
    March 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: 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 # 150476, LOT # 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. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION IS UNKNOWN.

    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
    136544 OSS DIAPHYSEL SEGMENT PROOSTHESIS KNEE JDI ZIMMER BIOMET, INC. N/A 215760

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R