BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 46

    MDR report key: 3962276 · Received July 29, 2014

    Report

    Report Number
    1818910-2014-24314
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    March 27, 2013
    Report Date
    July 23, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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. 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. 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.

    Additional Manufacturer Narrative · 1

    ASR REVISION ASR RESURFACING RIGHT REASON(S) FOR REVISION : NO HARM INFORMATION PROVIDED. LOT NUMBER SUPPLIED FOR CUP INCORRECT. UPDATE JUL 24, 2017. CLAIM LETTER RECEIVED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON: SEP 12, 2017. 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. 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

    ASR REVISION; ASR RESURFACING; RIGHT; REASON(S) FOR REVISION : NO HARM INFORMATION PROVIDED. LOT NUMBER SUPPLIED FOR CUP INCORRECT.

    Description of Event or Problem · 1

    UPDATE JUL 24, 2017. CLAIM LETTER RECEIVED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON: SEP 12, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442262 TOTAL ASR FEM IMP SIZE 46 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD.8010379 2212455

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention