BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EA DELTA CER INSERT 36IDX52OD

    MDR report key: 13894292 · Received March 24, 2022

    Report

    Report Number
    1818910-2022-05396
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 7, 2022
    Report Date
    March 24, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    P070026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR ANALYSIS. EXAMINATION OF THE PROVIDED PHOTOGRAPHS CONFIRMED THE REPORTED EVENT. CERAMIC INSERT CAN BE OBSERVED FRACTURED INTO SEVERAL PIECES. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> SHOP ORDERS (B)(4) AND (B)(4) WERE IDENTIFIED FOR THE INSERT. PROTOCOLS AND CERTIFICATE OF CONFORMANCE OF EACH LOT NUMBER WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE DATA OBTAINED ON THE INSERT CONFORMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PREEXISTING MATERIAL DEFECT. DEVICE HISTORY REVIEW ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (121881752/9921087) PRODUCT AND LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR ANALYSIS. EXAMINATION OF THE PROVIDED PHOTOGRAPHS CONFIRMED THE REPORTED EVENT. CERAMIC INSERT CAN BE OBSERVED FRACTURED INTO SEVERAL PIECES. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> SHOP ORDERS 7011638075 AND 7011642681 WERE IDENTIFIED FOR THE INSERT. PROTOCOLS AND CERTIFICATE OF CONFORMANCE OF EACH LOT NUMBER WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE DATA OBTAINED ON THE INSERT CONFORMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PREEXISTING MATERIAL DEFECT. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (121881752/9921087) PRODUCT AND LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. THE CERAMIC INSERT WAS FRACTURED INTO MULTIPLE PIECES. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : THE CERAMIC INSERT BELONGS TO THE SHOP ORDER (B)(4) . PROTOCOLS AND ACCEPTANCE CERTIFICATE WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE DATA OBTAINED ON THE INSERT CONFIRMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (121881752/9921087) PRODUCT AND LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    DURING THE SURGERY, WHEN OPENED THE PACKING, CRACKS WERE FOUND ON THE SURFACE OF THE PRODUCT. AFTER BLOWS, THE LINER WAS BROKEN. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE AFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797511 EA DELTA CER INSERT 36IDX52OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 9921087

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown