BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 18MM

    MDR report key: 5924180 · Received September 2, 2016

    Report

    Report Number
    0001825034-2016-03472
    Event Type
    Injury
    Date Received
    September 2, 2016
    Date of Event
    September 20, 2016
    Report Date
    October 4, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03471 / 03473). DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS: CATALOG #: 150478, OSS POLY LOCK PIN, LOT # 372750. CATALOG #: 150478, OSS POLY LOCK PIN, LOT # 233570. CATALOG #: 150476, OSS POLY TIBIAL BUSHING, LOT # 336790. CATALOG #: 150470, OSS 15CM DIAPHYSEAL SEGMENT, LOT # 583090. CATALOG #: 150444, OSS CMNTD PROX TIB STEM 9 X150, LOT # 296760. CATALOG #: 0014001, GENTAMICIN BONE CEMENT, LOT # 71794257. CATALOG #: 178556, CPS SHORT ANCHOR PLUG, LOT # 223410. CATALOG #: 178369, CPS LG SHT SPDL W PINS, LOT # 996140. CATALOG #: 150477, OSS POLY FEMORAL BUSHING, LOT # 277400. CATALOG #: 178540, CPS CENTERING SLEEVE 1, LOT # 047080. CATALOG #: 178528, CPS TRANSVERSE PIN 6PK, LOT # 494530. CATALOG #: 150483, OSS SEGMENTAL STACKING, LOT # 542350. CATALOG #: 150480, OSS AXLE, LOT # 879150. CATALOG #: 178512, CPS NUT, LOT # 751870. CATALOG #: 150354, OSS 7CM SEGMENTAL FEMORAL, LOT # 611160. CATALOG #: 178711, CPS/OSS 5CM TPR ADAPTOR, LOT # 751910. CATALOG #: 150419, OSS NON-MOD TIB PLATE, LOT # 379660. CATALOG #: 150493, OSS REINFORCED YOKE, LOT # 548590.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    A RIGHT KNEE REVISION PROCEDURE HAS BEEN INDICATED DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO LIMB SHORTENING RESULTING FROM MULTIPLE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577443 OSS TIBIAL POLY BEARING 18MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 390460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R