BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EA DELTA CER INSERT 36IDX52OD

    MDR report key: 11412882 · Received March 4, 2021

    Report

    Report Number
    1818910-2021-04357
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 18, 2021
    Report Date
    February 18, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED FRACTURE. 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 PROVIDED INSERT CAN BE UNIQUELY IDENTIFIED THROUGH THE LASER MARKING. SHOP ORDER (B)(4) WAS IDENTIFIED FOR THE INSERT. PROTOCOLS AND ACCEPTANCE CERTIFICATE WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE DATA OBTAINED ON THE INSERT CONFORMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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

    DURING HIP ARTHROPLASTY, THE CERAMIC INSERT BIOLOX DELTA CERAMAX INSERT 36 MM ID 52MM OD REF 1218-81-752, LOT 9171466 WAS BROKEN. THE INSERT WAS REMOVED FROM THE ACETABULUM AND REPLACED WITH PINNACLE ALTRX POLYETHYLENE ACETABULAR LINER LIPPED, 32 MM REF 1221- OD. 32-252 LOT J7071K. THE OPERATION WAS COMPLETED WITHOUT COMPLICATIONS RESULTING FROM A RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310841 EA DELTA CER INSERT 36IDX52OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS LZO DEPUY ORTHOPAEDICS INC US 9171466

    Patients

    Seq Age Sex Outcome Treatment
    1