BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 60

    MDR report key: 2011302 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-03042
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    May 26, 2011
    Report Date
    August 6, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. 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. REF. WWCAPA (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

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US.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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: ASR REVISION, ASR HIP RESURFACING SYSTEM (LEFT), REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION, UPDATE REC'D 06 AUG 2013- NEW REVISION DATE UPDATE 24 JUL 2017: CLAIM LETTER RECEIVED. UPDATED PRODUCT INFORMATION AND ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON: SEP 01, 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.

    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.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE: REASON FOR REVISION, SYSTEM AND HIP FROM (B)(4) SPREADSHEET 21 FEB 2012.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.UPDATE: REASON FOR REVISION, SYSTEM AND HIP FROM (B)(4) SPREADSHEET (B)(6) 2012.

    Description of Event or Problem · 1

    UPDATE 24 JUL 2017: CLAIM LETTER RECEIVED. UPDATED PRODUCT INFORMATION AND ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON: SEP 01, 2017.

    Description of Event or Problem · 1

    THE PT HAS HAD AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 60 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2363002

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention