BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ACETABULAR SCREW

    MDR report key: 4172832 · Received October 15, 2014

    Report

    Report Number
    1818910-2014-29379
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 21, 2011
    Report Date
    March 15, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. FOR ANY PRODUCT INFORMATION RECEIVED. FOLLOW-UP WITH THE COMPLAINT HAS BEEN CONDUCTED FOR THE CATALOG NUMBER AND LOT NUMBER AND THIS INFORMATION IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION FOR PINN REVISION W/ GRIPTION AND ALTRX +410D 36IDX54OD SINCE RELEASE FOR DISTRIBUTION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE FOR THE UNKNOWN LOT CODES FOR THE SCREWS. PROVIDED INFORMATION STATES THE PATIENT HAD POOR BONE QUALITY WHICH ALLOWED THE CUP TO ROTATE; ALSO FORCED THE SCREW TO BREAK. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. REVIEW OF PROVIDED MEDICAL RECORDS FOUND THE EVENT WAS NOT DEVICE RELATED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE. 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.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT - PATIENT WAS REVISED TO ADDRESS ACETABULAR LOOSENING DUE TO LACK OF MEDIAL/SUPERIOR BONE SUPPORT. THE CUP ROTATED HORIZONTALLY/TRANSLATED MEDIALLY RESULTING IN SCREW BREAKAGE ON THE LATERAL EDGE OF THE CUP. OSTEOLYSIS WAS DISCOVERED INTRAOPERATIVELY. DOI: (B)(6) 2011 - DOR: (B)(4) 2011 (RIGHT HIP). UPDATE - (B)(6) 2012: LITIGATION DOCUMENTS WERE RECEIVED. LITIGATION ALLEGES THAT THE PATIENT HAD TWO REVISION PROCEDURES. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE REC'D 3/15/2013- PPD AND MEDICAL RECORDS RECEIVED. THE REVISION OPERATIVE NOTE INDICATED THE CUP WAS LOOSE, 1 SCREW WAS BROKEN, AND 2 SCREWS WERE LOOSE. THE MDR DECISIONS FOR THE CUP AND 2 CURRENT SCREWS ARE BEING REVISITED. ONE SCREW IS BEING ADDED TO THE COMPLAINT. OSTEOLYSIS WAS ALSO NOTED. THE CUP WAS ALSO NOTED TO BE MALPOSITIONED DUE TO LOOSENING. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE REC'D (B)6) 2013- PPD AND MEDICAL RECORDS RECEIVED. THE REVISION OPERATIVE NOTE INDICATED THE CUP WAS LOOSE, 1 SCREW WAS BROKEN, AND 2 SCREWS WERE LOOSE. THE MDR DECISIONS FOR THE CUP AND 2 CURRENT SCREWS ARE BEING REVISITED. ONE SCREW IS BEING ADDED TO THE COMPLAINT. OSTEOLYSIS WAS ALSO NOTED. THE CUP WAS ALSO NOTED TO BE MALPOSITIONED DUE TO LOOSENING. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653921 UNKNOWN DEPUY ACETABULAR SCREW HIP OTHER IMPLANT: SCREW HWC DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention