BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCPS 800LB MT SPDL

    MDR report key: 6957603 · Received October 18, 2017

    Report

    Report Number
    0001825034-2017-08628
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    January 27, 2015
    Report Date
    October 12, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PCUSTOMIZED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM#178410; LOT#118180 ¿ CPS ANCHOR PLUG 20MM; ITEM#178546; LOT#156730 ¿ CPS CENTERING SLEEVE 24MM; ITEM#178527; LOT#446850 ¿ CPS TRANSVERSE PIN 6PK 32MM; ITEM#178528; LOT#644210 ¿ CPS TRANSVERSE PIN 6PK 36MM; ITEM#178512; LOT#982970 ¿ CPS NUT CO-CR-MO ALLOY; ITEM#CP115443; LOT#907040 ¿ CUST TCPS ADAPTER +2CM. THE PRODUCT WAS RECEIVED BY ZIMMER BIOMET. THE PATIENT INCORRECTLY PROGRAMMED HIS EXTERNAL PROSTHETIC LIMB WHICH CAUSED A FALL RESULTING IN A CRUSHED/FRACTURED FEMUR. THE TRANSDERMAL/COMPRESS DEVISES USED WERE DAMAGED DURING THE FALL BUT DID NOT FAIL. THE PATIENT WILL NOW UNDERGO A 1 - STAGE REVISION TO PUT IN NEW CUSTOM IMPLANTS ON AN UNKNOWN DATE. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL ISSUES REPORTED FOR THIS PART. RELAYED RESULTS OF INVESTIGATION TO SALES REP VIA EMAIL ON (B)(6) 2015. ASKED REP TO VERBALLY RELAY RESULTS TO CUSTOMER. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN TRANSFEMORAL AMPUTATION ON AN UNKNOWN DATE. THE PATIENT UNDERWENT A REVISION ON (B)(6) 2013 WHERE HE WAS IMPLANTED WITH A COMPRESS ENDO-EXO PROSTHESIS DUE TO SKIN PROBLEMS WITH HIS OLD PROSTHESIS SLEEVE, NOT BIOMET PRODUCT RELATED. THE PATIENT HAD A PMI CUSTOM TAPER ADAPTER IMPLANTED ON (B)(6) 2014 AS A STAGE TWO REVISION. THIS WAS IMPLANTED A MONTH AFTER HIS REVISION BECAUSE THE WOUND FROM THE REVISION PROCEDURE NEEDED TO HEAL BEFORE THE TAPER ADAPTOR WAS PUT IN. SUBSEQUENTLY, THE SURGEON STATED, "PATIENT INCORRECTLY PROGRAMED HIS NEW EXTERNAL PROSTHETIC LIMB, WHICH WENT INTO IMMEDIATE FULL FLEXION WHICH CAUSED A FALL RESULTING IN A CRUSHED/FRACTURED FEMUR IN THE PERIPROSTHETIC REGION." DUE TO THIS FALL, IT WAS REPORTED THAT THE PATIENT HAD ALL OF HIS IMPLANTS REMOVED ON (B)(6) 2015. THE PATIENT UNDERWENT A STAGE 1 REVISION TO PUT IN NEW CUSTOM IMPLANTS ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736842 TCPS 800LB MT SPDL PROSTHESIS - KNEE JWH ZIMMER BIOMET, INC. N/A 302050

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R