BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS CENTERING SLEEVE

    MDR report key: 9608433 · Received January 20, 2020

    Report

    Report Number
    0001825034-2020-00319
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    December 26, 2017
    Report Date
    March 17, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K043547
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. IT IS NOW VERIFIED THAT THIS DEVICE IS NOT RELATED TO THE EVENT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. IT IS NOW VERIFIED THAT THIS DEVICE IS NOT RELATED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CPS NUT CO-CR-MO ALLOY CATALOG # 178512 LOT # 526830, CPS SHORT ANCHOR PLUG 12MM CATALOG # 178554 LOT # 264440, CPS XS SHT SPDL W PINS 400LBF CATALOG # 178362 LOT # 502610, CPS TRANSVERSE PIN 6PK 28MM CATALOG # 178526 LOT # 837860, OSS RS AXLE CATALOG # 161035 LOT # 661010, OSS REINFORCED YOKE CATALOG # 150493 LOT # 815900, OSS POLY LOCK PIN CATALOG # 150478 LOT # 066500, CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG # 178711 LOT # 108540, OSS RS 12MM LS TIBIAL BEARING CATALOG # 161094 LOT # 201270, OSS RS POLY FEM BUSHINGS SET/2 CATALOG # 161034 LOT # 456570, OSS RS NON MOD PLATE LONG 67 CATALOG # 161039 LOT # 975750, OSS RS 8.5CM SEG FMRL RIGHT CATALOG # 161123 LOT # 540030, OSS POLY TIBIAL BUSHING CATALOG # 150476 LOT # 132820, CPS TRANSVERSE PIN 6PK 24MM CATALOG # 178525 LOT # 730800. 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. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2020-00250, 0001825034-2020-00316, 0001825034-2020-00317, 0001825034-2020-00318. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ORTHOPEDIC SALVAGE PROCEDURE. THE PATIENT ALLEGEDLY EXPERIENCED THE KNEE GIVING OUT WHICH RESULTED IN THE PATIENT FALLING TO THE GROUND MULTIPLE TIMES. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FEMUR FRACTURE AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70942 CPS CENTERING SLEEVE PROSTHESIS, KNEE LPH ZIMMER BIOMET, INC. N/A 318820

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| R