BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL TAP SLV ADAP 12/14+2

    MDR report key: 1905564 · Received November 19, 2010

    Report

    Report Number
    1818910-2010-07991
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    July 6, 2008
    Report Date
    August 13, 2012
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SPECIFIC REASON FOR THE PT'S REVISION IS UNK, BECAUSE THE PT'S CLAIM HAS BEEN APPROVED BY DEPUY'S THIRD-PARTY CLAIMS ADMINISTRATOR, IT IS REASONABLE TO CONCLUDE THAT THE REASON FOR THE REVISION HAS BEEN DETERMINED TO BE PRODUCT-RELATED. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT NO PRODUCT WAS RETURNED. THE PRIMARY SURGERY DATE WAS (B)(6) 2007 AND THE REVISION SURGERY DATE WAS (B)(6) 2008, MEANING THAT THE PRODUCTS WERE IMPLANTED FOR (B)(6) MONTHS. DUE TO THE LENGTH OF IMPLANTATION TIME IT IS NOT CONSIDERED THAT THE IMPLANTS WERE RESPONSIBLE FOR THE INFECTION. A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED ON LOTS 2488936 AND 2455511 WITH THE RESULT THAT NO ANOMALIES WERE FOUND. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT 2460896 IDENTIFIED THAT ONE DEVIATION WAS RAISED (DEV2455). REVIEW OF DEV2455 IDENTIFIED THAT IT WAS RAISED TO ALLOW TRANSFER OF PRODUCT TO A NEW MACHINE TO INCREASE PRODUCTION. IT WAS CONFIRMED THAT THIS DEVIATION SHOULD HAVE HAD NO EFFECT ON THE REPORTED INCIDENT. THE IRRADIATION CERTIFICATES FOR LOTS 2460896, 2455511, AND 2488936 SHOW THE DOSE TO BE WITHIN ALLOWABLE LIMITS AND NO OTHER ANOMALIES WERE FOUND. COPIES OF THE CERTIFICATES HAVE BEEN ATTACHED TO THE COMPLAINT. WITH THE INFORMATION AVAILABLE THE INVESTIGATION WILL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND ENTERED INTO THE COMPLAINTS DATABASE FOR FUTURE TRENDING. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    CORRECTED/UPDATED DATA: (DATE OF EVENT); (DATE OF REPORT); (EVENT DESCRIPTION); (DEVICE PRODUCT CODE); (DATE RECEIVED BY MANUFACTURER); (REMEDIAL ACTION INDICATED); (CORRECTION/REMOVAL NUMBER). THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Description of Event or Problem · 1

    ASR REVISION - LEFT HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE ASR LEFT HIP IMPLANT. THE REASON FOR THE REVISION WAS INFECTION (TESTED AND POSITIVE CULTURE CONFIRMED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR XL TAP SLV ADAP 12/14+2 HIP KWA DEPUY INTERNATIONAL, LTD. NA 2488936

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention