BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 2232826 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-14991
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    April 1, 2011
    Report Date
    November 4, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 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. 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

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ASR REVISION. ASR XL ACETABULAR SYSTEM (LEFT). REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION; ASR XL ACETABULAR SYSTEM (LEFT); REASON FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE - ADDED PRODUCTS X 2 (STEM AND SLEEVE) QUERYING IMPLANT DATE AS IT IS BEFORE MANUFACTURING DATES. TAKEN FROM CLAIMSUITE DATED 24TH OCTOBER 2014. UPDATE - RECEIVED RESPONSE TO QUERY - THE DATES ORIGINALLY PROVIDED DID NOT MATCH AS THIS IS A RESURFACING TO XL. CORRECT DATES NOW RECEIVED - NOW QUERYING REASON FOR REVISION, HOSPITAL, AND SURGEON FOR BOTH SURGERIES. SEE (B)(4) DATED 29TH OCTOBER 2014 FOR PRIMARY SURGERY SEE (B)(4).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR XL ACETABULAR SYSTEM (LEFT). REASON FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE - ADDED PRODUCTS X 2 (STEM AND SLEEVE) QUERYING IMPLANT DATE AS IT IS BEFORE MANUFACTURING DATES. TAKEN FROM CLAIMSUITE DATED 24TH OCTOBER 2014. UPDATE - RECEIVED RESPONSE TO QUERY - THE DATES ORIGINALLY PROVIDED DID NOT MATCH AS THIS IS A RESURFACING TO XL. CORRECT DATES NOW RECEIVED - NOW QUERYING REASON FOR REVISION, HOSPITAL, AND SURGEON FOR BOTH SURGERIES. SEE EMAIL DATED 29TH OCTOBER 2014. FOR PRIMARY SURGERY SEE (B)(4). UPDATE - RECEIVED REASON FOR REVISION TAKEN FROM EMAIL DATED 4TH NOV 2014. REASON FOR REVISION - COMPONENT LOOSENED HEAD, PAIN AND ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2752299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention