BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EA DELTA CER INSERT 36IDX52OD

    MDR report key: 7288377 · Received February 22, 2018

    Report

    Report Number
    1818910-2018-53885
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    January 1, 2016
    Report Date
    January 31, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER.  THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    (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 · 1

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

    Additional Manufacturer Narrative · 1

    PC(B)(4).THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: 8355176 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

    I HAVE BEEN TOLD THAT A CERAMIC HEAD HAS BEEN BROKEN IN A HOSPITAL IN (B)(6). THE DISTRIBUTOR WILL BE PROVIDING FURTHER DETAILS. UNTIL I GET THEM, I OPEN THE DEVICE REPORT WITH THE ONLY INFORMATION I HAVE UNTIL NOW. SALES REP ADDED WRONG "OPCO" SO WE HAD TO VOID AND CREATE A NEW COMPLAINT. ORIGINAL/VOIDED COMPLAINT HAS ID: (B)(4). SALES REP. HAS SENT ME MORE INFORMATION: ON THE DATE 9/11/2016 A PATIENT WAS OPERATED WITH A CERAMIC ON CERAMIC BEARING. THE CERAMIC INSERT WAS THE REFERENCE 1218-81-752 WITH THE LOT 8355176. THE HEAD WAS 1365-36-310 WITH THE LOT 8368672. ON THE (B)(6) 2016, THE PATIENT WENT TO THE DOCTOR REFERRING PAIN AND SQUEAKING IN THE OPERATED HIP. ON THE (B)(6) 2016, THE PATIENT UNDERWENT SURGERY. THEY FOUND OUT THAT THE CERAMIC LINER WAS BROKEN AND NEEDED TO BE REPLACED. ALL THE REFERENCES AND LOTS HAVE BEEN REPORTED. THE HOSPITAL WOULD LIKE TO KNOW IF THERE IS A PROBLEM ON THE MATERIAL OR HAS IT BEEN A MAL ALIGNMENT OF THESE PARTS IN THE FIRST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134033 EA DELTA CER INSERT 36IDX52OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS LZO DEPUY ORTHOPAEDICS, INC. 1818910  8355176

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention