BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TENSION BAND WIRE

    MDR report key: 16158352 · Received January 13, 2023

    Report

    Report Number
    0001822565-2023-00115
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    January 3, 2014
    Report Date
    March 22, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LHX
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED AS X-RAYS WERE REVIEWED AND IT WAS FOUND THAT THE INITIAL COMMINUTED AND DISPLACED DISTAL HUMERAL FRACTURE WITH SUBSEQUENT PLATE AND SCREW FIXATION. REMOVAL OF THE INITIAL HARDWARE WITH FRACTURE NON-UNION. SUBSEQUENT REVISION WITH NEW PLATE AND SCREW FIXATION OF THE HUMERAL FRACTURE AND PROXIMAL ULNA FIXATION AS NOTED. SLIGHT RETRACTION OF ONE OF THE DISTAL HUMERAL SCREWS WAS NOTED. NO OTHER OVERALL CHANGE IN HARDWARE POSITION OR FRACTURE ALIGNMENT WITH CONTINUED SUSPECTED FRACTURE NON-UNION. THE MEDICAL RECORDS ALSO INDICATED THAT THE PATIENT HAD PAIN AND CT SCAN SHOWED SIGNS OF NON-UNION. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: CATALOG#: UNKNOWN, ZB 9 HOLE PLP PLATE, LOT# UNKNOWN. CATALOG#: UNKNOWN, ZB MEDIAL PLATE, LOT# UNKNOWN. CATALOG#: UNKNOWN, SMALL FRAGMENT SCREW, LOT# UNKNOWN QTY (B)(4). CATALOG #: UNKNOWN, SMALL WASHERS X2, LOT# UNKNOWN QTY (B)(4). CORRECTION TO N/A: D6B. 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 · 0

    (B)(4). REPORT SOURCE: UK. CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 47235800805, DISTAL MEDIAL HUMERAL PLATE LEFT 5 HOLES, LOT # UNKNOWN, CATALOG #: 47235800607, DISTAL POSTERIOR/LATERAL HUMERAL PLATE LEFT, LOT # UNKNOWN, CATALOG #: UNKNOWN, ZPLP 3.5MM LOCKING SCREWS, LOT # UNKNOWN QTY. 2, CATALOG #: UNKNOWN, ZPLP 2.7MM LOCKING SCREWS, LOT # UNKNOWN QTY 7. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED. 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: 0001822565-2023-00109, 0001822565-2023-00110, 0001822565-2023-00111, 0001822565-2023-00112, 0001822565-2023-00113, 0001822565-2023-00114, 0001822565-2023-00116, 0001822565-2023-00117, 0001822565-2023-00118, 0001822565-2023-00120, 0001822565-2023-00121.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN INITIAL LEFT ELBOW OPEN REDUCTION INTERNAL FIXATION OF SUPRACONDYLAR HUMERUS APPROXIMATELY 10 YEARS AGO. EXPLANTED OF ALL HARDWARE ABOUT 9 MONTHS LATER FOR NONUNION OF FRACTURE. SUBSEQUENTLY 3 MONTHS LATER RE-FIXATION OF LEFT ELBOW WITH ORIF OF NON-UNION HUMERUS SHAFT WITH BONE GRAFT AND HARVEST ILIAC CREST BONE. PLATES, SCREWS, ALLOGRAFT, TENSION BAND ALONG WITH HARVESTED BONE GRAFT WERE USED TO FIX HUMERUS FRACTURE. ELEVEN MONTHS LATER PATIENT CONTINUES WITH PAIN AND DECREASED ROM. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL DISTAL MEDIAL AND POSTEROLATERAL HUMERAL PLATING. SUBSEQUENTLY, DURING THE RETROSPECTIVE REVIEW OF THE CLINICAL DATA, IT WAS NOTED THAT THE PATIENT EXPERIENCED PROMINENT METALWORK AND UNDERWENT REMOVAL OF THE HARDWARE SIX YEARS POST INITIAL IMPLANTATION. DURING THE REVISION, A NONUNION WAS PRESENT, BUT NO ADDITIONAL HARDWARE WAS IMPLANTED AT THIS TIME. ON AN UNKNOWN DATE AN ADDITIONAL SURGERY WAS LATER PERFORMED DUE TO NON-UNION AND BONE GRAFT WAS PLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751168 UNK TENSION BAND WIRE TRAUMA IMPLANT LHX ZIMMER BIOMET, INC. N/A N/A
    999274 UNK TENSION BAND WIRE TRAUMA IMPLANT LHX ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention| H SEE H10.| SEE H10.