BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A.L.P.S.CORTICAL LOCKING SCREW

    MDR report key: 8996549 · Received September 11, 2019

    Report

    Report Number
    0001825034-2019-04063
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    July 10, 2019
    Report Date
    January 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    K143697
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H10 REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE TIBIAL AND FIBULAR ARE FRACTURED. FRACTURE OF THE TIBIAL PLATE AND THE MOST PROXIMAL TIBIAL FIXATION SCREW. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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: 856202012, DIST TIB ANTLAT R NRW 12H STE, 688520; 856135030, 3.5X30MM CORT LOCK SCR STE, 452510; 856135032, 3.5X32MM CORT LOCK SCR STE, 532730; 856135032, 3.5X32MM CORT LOCK SCR STE, 774040; 856135034, 3.5X34MM CORT LOCK SCR STE, 120400; 856135040, 3.5X40MM CORT LOCK SCR STE, 120550; 856135042, 3.5X42MM CORT LOCK SCR STE, 149770; 856135042, 3.5X42MM CORT LOCK SCR STE, 433990; 851218000, 3.5MM LOW PRO CORT WASHER STE, 558360; 851218000, 3.5MM LOW PRO CORT WASHER STE, 955000; 851235018, 3.5X18MM LOW PRO CORT SCR STE, 883080; 851235032, 3.5X32MM LOW PRO CORT SCR STE, 222000. FOREIGN SOURCE: (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. 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: 0001825034-2019-03243, 0001825034-2019-03446-1, 0001825034-2019-04058, 0001825034-2019-04059, 0001825034-2019-04060, 0001825034-2019-04062, 0001825034-2019-04065, 0001825034-2019-04066, 0001825034-2019-04069, 0001825034-2019-04070. REQUESTED BUT NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INITIAL SURGERY WAS PERFORMED WITH ALPS PLATES AND SCREWS TO FIX THE DISTAL TIBIAL BONE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO FRACTURE OF THE PLATE AND PROXIMAL TIBIAL SCREW. THE PATIENT'S BONE DID NOT HEAL AS EXPECTED POST INITIAL PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791983 A.L.P.S.CORTICAL LOCKING SCREW SCREW, FIXATION, BONE HRS ZIMMER BIOMET, INC. N/A 939680

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE NARRATIVE IN H10