BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 3CM TAPERED DIAPH SEGMENT

    MDR report key: 8848056 · Received July 31, 2019

    Report

    Report Number
    0001825034-2019-03305
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    July 5, 2019
    Report Date
    November 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K141331
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS TIBIAL POLY BEARING 12MM; P/N: 150410, L/N: 121890. OSS RS 7 CM MOD SEG FMRL-LT; P/N: 161012, L/N: 271570. OSS MOD TIB BASEPLATE 79MM; P/N: 150424, L/N: 099180. OSS POLY TIBIAL BUSHING; P/N: 150476, L/N: 438740. OSS RS POLY FEM BUSHINGS SET/2; P/N: 161034, L/N: 738450. OSS POROUS IM STEM 17.5 X 90; P/N: 150388, L/N: 468310. OSS REINFORCED YOKE; P/N: 150493, L/N: 169890. OSS RS AXLE; P/N: 161035, L/N: 625250. OSS POLY LOCK PIN; P/N: 150478, L/N: 820520. OSS SEGMENTAL STACKING ADAPTER; P/N: 150483, L/N: 600580. OSS SEGMENTAL STACKING ADAPTER; P/N: 150483, L/N: 489400. OSS 3CM TAPERED DIAPH SEGMENT; P/N: 151836, L/N: 680070. OSS 3CM TAPERED DIAPH SEGMENT; P/N: 151836, L/N: 151760. CPS/OSS 5CM TPR ADAPT W/OSS SC; P/N: 178711, L/N: 297440. CPS NUT CO-CR-MO ALLOY; P/N: 178512, L/N: 099440. CPS CENTERING SLEEVE 16MM; P/N: 178538, L/N: 349230. CPS SM SPDL WITH PINS 600LBF; P/N: 178354, L/N: 953500. CPS TRANSVERSE PIN 6PK 28MM; P/N: 178526, L/N: 297740. CPS ANCHOR PLUG 14MM; P/N: 178404, L/N: 608590. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03290, 0001825034-2019-03292, 0001825034-2019-03293, 0001825034-2019-03294, 0001825034-2019-03296, 0001825034-2019-03297, 0001825034-2019-03299, 0001825034-2019-03300, 0001825034-2019-03301, 0001825034-2019-03302, 0001825034-2019-03303, 0001825034-2019-03304, 0001825034-2019-03338, 0001825034-2019-03340, 0001825034-2019-03341, 0001825034-2019-03342, 0001825034-2019-03343, 0001825034-2019-03344. DEVICE EVALUATED BY MFR: PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION PROCEDURE 3 MONTHS POST IMPLANTATION DUE TO INFECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639526 OSS 3CM TAPERED DIAPH SEGMENT PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 151760

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R