BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ORTHOCORD

    MDR report key: 9155784 · Received October 4, 2019

    Report

    Report Number
    1221934-2019-58795
    Event Type
    Injury
    Date Received
    October 4, 2019
    Report Date
    October 3, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ANDRAS HEIJINK, ET AL, 2015 ¿DISTAL HUMERUS PROSTHETIC HEMIARTHROPLASTY: MIDTERM RESULTS¿, STRAT TRAUM LIMB RECON 10: PAGES 101-108 (NETHERLANDS). THE PURPOSE OF THIS STUDY WAS TO REPORT THE MIDTERM RESULTS OF SIX PATIENTS THAT WERE TREATED BY DHA FOR ACUTE AND SALVAGE TREATMENT OF NON-RECONSTRUCTABLE FRACTURES OF THE DISTAL HUMERUS. SIX PATIENTS WERE TREATED IN OUR INSTITUTION BY DISTAL HUMERUS PROSTHETIC HEMIARTHROPLASTY (DHA) BETWEEN APRIL 2006 AND NOVEMBER 2009: ONE WAS TREATED FOR A CLOSED NON-RECONSTRUCTABLE FRACTURE OF THE DISTAL HUMERUS, WHILE FIVE WERE TREATED FOR FAILED EARLIER TREATMENT AND/OR SEQUELAE OF SUCH A FRACTURE WITHOUT REALISTIC RECONSTRUCTION OPTIONS. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURES: DISTAL HUMERUS HEMIARTHROPLASTY (DHA) INVOLVES REPLACEMENT OF THE DISTAL HUMERUS BY A HUMERAL COMPONENT OF A CONVERTIBLE TOTAL ELBOW SYSTEM, MOUNTED WITH AN ANATOMICAL SPOOL. DHA IS CONSIDERED AN 'UNLINKED' CONSTRUCTION AND THEREFORE MUST MIMIC THE NATIVE DISTAL HUMERUS ANATOMY IN ORDER TO PROVIDE OPTIMAL STABILITY AND TRANSMISSION OF FORCES. THE IMPLANT MUST BE INSERTED AT THE CORRECT LEVEL AND ORIENTATION TO RESTORE THE AXIS OF FLEXION IN RELATION TO THE INSERTIONS OF THE MEDIAL AND LATERAL COLLATERAL LIGAMENTS. THE DEVICE INVOLVED: ORTHOCORD. COMPLICATIONS MENTIONED IN THE STUDY: MEAN FOLLOW-UP WAS 54 MONTHS (RANGE 21-76 MONTHS). IMPLANT SURVIVAL WAS 100 %. THREE WERE PAIN FREE AND THREE HAD MILD OR MODERATE RESIDUAL PAIN. AVERAGE FLEXION-EXTENSION ARC WAS 95.8° (RANGE 70°- 115°) AND AVERAGE PRONATION-SUPINATION ARC WAS 165° (RANGE 150°-180°). IN THREE, THERE WAS SOME DEGREE OF INSTABILITY, WHICH WAS SYMPTOMATIC IN ONE. ONE HAD MOTORIC AND SENSORY SEQUELAE OF A PARTIALLY RECOVERED TRAUMATIC ULNAR NERVE LESION. ACCORDING TO THE MAYO ELBOW PERFORMANCE SCORE, THERE WERE THREE EXCELLENT, ONE GOOD AND TWO POOR RESULTS. FOUR WERE SATISFIED WITH THE FINAL RESULT, AND TWO WERE NOT. IN THIS CASE SERIES OF SIX PATIENTS WITH DHA FOR NON-RECONSTRUCTABLE DISTAL HUMERUS FRACTURES, FAVORABLE MIDTERM FOLLOW-UP RESULTS WERE SEEN; HOWEVER, COMPLICATIONS WERE ALSO OBSERVED. A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948913 UNKNOWN ORTHOCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention