BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 58

    MDR report key: 1911649 · Received November 29, 2010

    Report

    Report Number
    1818910-2010-09105
    Event Type
    Injury
    Date Received
    November 29, 2010
    Report Date
    June 24, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    CORRECTED: BRAND NAME, COMMON DEVICE NAME/DEVICE PRODUCT CODE, CATALOG #/LOT #, EXPLANT DATE, 510K, MANUFACTURE DATE. 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT WILL NEED TO BE REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION REPORT OF THE LEFT HIP INDICATES PATIENT HAD ON-GOING PAIN, DISABILITY AND A HIGH COBALT LEVEL. UPON REVISION, THE FOLLOWING WAS FOUND: THIN, YELLOW, CLOUDY FLUID; FAIR AMOUNT OF SCAR TISSUE SURROUNDING THE ARTICULATION; SLIGHT AMOUNT OF METALLOSIS AT THE HEAD AND NECK JUNCTION; EVIDENCE OF FIBROUS INGROWTH ON THE BACK SIDE OF THE CUP. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUP SIZE 58 ACETABULAR SHELL KWA DEPUY INTERNATIONAL, LTD. NA 2773912

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention