BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METAGLENE SCREWS DIA 4.5X24MM

    MDR report key: 4220697 · Received November 3, 2014

    Report

    Report Number
    1818910-2014-30927
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR ANALYSIS OF THE BATCHES PROVIDED SHOWS AN INITIAL CONFORMANCE OF THESE PRODUCTS WITH REGARDS TO THEIR SPECIFICATION. FOR THESE BATCHES, THERE WAS NO DEVIATION OR NON-CONFORMANCE. PRODUCT ANALYSIS: A METAGLENE SCREW BREAKAGE AND PE CUP WEAR IS NOTED ON THE PRODUCTS RETURNED. A DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED BECAUSE THE PARTS ARE DETERIORATED. REVIEW OF THE IMAGES PROVIDED: THREE IMAGES OF AN EXPLANTED DELTA HUMERAL CUP WERE RECEIVED FOR REVIEW. THE COMPLAINT DESCRIPTION INDICATES THAT THE CONSTRUCT WAS REVISED BECAUSE OF POLY WEAR AND METAGLENE LOOSENING. THE CONSTRUCT WAS IMPLANTED IN 2001 AND REMOVED IN 2014. THE IMAGES SHOW THAT THE RIM OF THE POLYETHYLENE COMPONENT WAS HEAVILY DAMAGED. HALF OF THE RIM IS DISCOLORED, STAINED, AND CHIPPED/WORN. THERE IS LITTLE DAMAGE VISIBLE TO ANY OTHER LOCATION. THE ARTICULATING SURFACE OF THE POLYETHYLENE IS MOSTLY SMOOTH WITH NO PITTING OR HEAVY WEAR. THERE IS ISOLATED GOUGING ON THE RIM OPPOSITE THE STAINED/WORN REGION. THIS GOUGING APPEARS TO HAVE BEEN A RESULT OF EXTRACTION. SEPARATE IMAGES FROM GREATBATCH SHOW THAT ONE OF THE ANCHOR SCREWS IS BROKEN. BECAUSE THE BREAK IS NOT MENTIONED IN THE DER IT IS NOT CLEAR WHEN OR WHY THE SCREW BROKE OR WHAT THE ORIGINAL LENGTH OF THE SCREW WAS. THERE IS NO IMAGE OF THE COMPONENTS IN SITU, BUT IT APPEARS REASONABLE TO ASSUME THAT THE DAMAGED RIM OF THE HUMERAL CUP WAS POSITIONED INFERIORLY. THIS COULD LEAD TO IMPINGEMENT OF THE DAMAGED PORTION OF THE CUP ON THE SCAPULA. OVER TIME, EVEN MINOR IMPINGEMENT WOULD RESULT IN THE TYPE OF ISOLATED WEAR THAT IS VISIBLE ON THIS HALF OF THE RIM. LATER REVERSE SHOULDER DESIGNS (E.G. DELTA XTEND) HAVE ALLEVIATED THIS ISSUE BY MOVING THE HUMERAL COMPONENT FARTHER FROM THE SCAPULAR NECK. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. LATE REASON- DUE TO AN INTERNATIONAL/(B)(4) INTERNAL ADMINISTRATIVE ERROR THIS PRODUCT WAS NOT REPORTED WITHIN THE THIRTY-DAY MDR DEADLINE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IMPLANTATION OF SHOULDER PROTHESIS DELTA CTA 3.1 IN 2001. REVISION IN (B)(6) 2014 BECAUSE OF PE WEAR (SEE PHOTO) AND LOOSENING OF METAGLENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701340 METAGLENE SCREWS DIA 4.5X24MM SHOULDER OTHER IMPLANT KWS DEPUY FRANCE SAS 3003895575 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention