BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO B-MTRC MP FP HO 10

    MDR report key: 7048598 · Received November 21, 2017

    Report

    Report Number
    0001825034-2017-10178
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    October 19, 2017
    Report Date
    December 4, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK143009
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UDI NUMBER - (B)(4). CONCOMITANT MEDICAL PRODUCTS: 006250006540, LOT#63745010; 650-1057-- CER BIOLOXD OPTION HD 36MM, LOT#2900741; 010000664-- G7 PPS LTD ACET SHELL 54F, LOT#6057995; 010000819-- G7 HI-WALL ARCOMXL LNR 36MM, F LOT#6121296; 650-1067-- CER OPTION TYPE 1 TPR SLEVE +3, LOT#2900742. THE REPORTED EVENT WAS CONFIRMED BASED ON X-RAY REPORTS AND OPERATIVE NOTES RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE COMPATIBILITY CHECK NOTED NO ISSUES. PRIMARY OP NOTES INDICATE PATIENT UNDERWENT THA DUE TO DEGENERATIVE END STAGE ARTHRITIS. IT WAS ALSO NOTED THAT THE PATIENT'S BONE STRUCTURE WAS RELATIVELY SMALL AND THAT THE COMPONENTS WERE IMPLANTED AND INDICATED EXCELLENT PLACEMENT, STABILITY AND GOOD RANGE OF MOTION. IT WAS NOTED THAT THE PATIENT WAS MORBIDLY OBESE. THE REVIEW OF THE REVISION OP NOTES INDICATED THAT THE PATIENT UNDERWENT A REVISION DUE TO PERIPROSTHETIC FRACTURE AND THE FEMORAL COMPONENT WAS REMOVED. X-RAY REVIEWS IDENTIFIED THAT THE HARDWARE APPEARED TO BE INTACT AND WELL SEATED. SUBTLE LINEAR LUCENCY WAS ALSO NOTED ALONG THE MEDICAL CORTEX OF THE RIGHT FEMORAL METADIAPHYSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED PAIN ONE DAY POST-PRIMARY IMPLANTATION. X-RAYS REVEALED A DISPLACED FEMORAL FRACTURE. PATIENT WAS SUBSEQUENTLY REVISED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830354 ECHO B-MTRC MP FP HO 10 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 346900

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R