BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 11697495 · Received April 20, 2021

    Report

    Report Number
    1818910-2021-08335
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    January 6, 2020
    Report Date
    April 6, 2021
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : LOT 8984346. A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: LOT 8984346. A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/ LOT COMBINATION. DEVICE HISTORY REVIEW: LOT 8984346. A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION. CORRECTED: MANUFACTURER DATE, CITY AND STATE.

    Description of Event or Problem · 1

    PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES NUMEROUS SUBSEQUENT SURGERIES, INFECTIONS, DISLOCATIONS, DAILY SPASMS IN NECK, RIGHT SHOULDER, LOWER RIGHT BUTTOCK, BOTH FEET AND LOWER LEGS, UNEVEN GATE, UNABLE TO BEAR FULL WEIGHT, UNABLE TO PERFORM ACTIVITIES OF DAILY LIVING. RIGHT HIP STILL WITH ORIGINAL IMPLANT DEVICE AND STILL CAUSING METALOSIS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR REMOVAL OF LEFT HIP ANTIBIOTIC SPACER, CONVERSION OF LEFT THA MODIFIER 22 FOR COMPLEX SURGICAL FIELD AND SIGNIFICANT SCAR TISSUES. OPERATIVE NOTE REPORTED THAT DURING INCISION IT WAS DENSELY SCARRED IN. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589942 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 3122-040 8984346 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention (FREEDOM CUP)| (FREEDOM HEAD)| COMPETITOR| PROSTALAC LT 200 STEM SZ3| SMARTSET MV 40G - EO