BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 58

    MDR report key: 1943975 · Received December 3, 2010

    Report

    Report Number
    1818910-2010-08570
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    February 28, 2011
    Report Date
    November 3, 2010
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SPECIFIC NATURE OF THE PT'S COMPLAINT IS UNK, BECAUSE REVISION HAS BEEN RECOMMENDED BY DEPUY'S THIRD PARTY CLAIMS ADMINISTRATOR, IT IS REASONABLE TO CONCLUDE THAT THE PT'S COMPLAINT 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 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). 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. THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER SINCE IT IS ONLY INDICATED TO BE USED AS A HEMI IN THE US AT THIS TIME. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4) IS USED TO CAPTURE (DEVICE REVISION OR REPLACEMENT).

    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.

    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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-001226. ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. 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

    RECOMMENDED ASR REVISION - RIGHT HIP.

    Description of Event or Problem · 1

    REVISED FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 58 87KWA KWA DEPUY INTERNATIONAL LTD - 8010379 NA 1852239

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention