BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED ASR CUP

    MDR report key: 3073604 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-05075
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    December 8, 2011
    Report Date
    February 6, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    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

    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.

    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

    .

    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 XL - LEFT. REASON(S) FOR REVISION: PAIN AND ALVAL / SOFT TISSUE REACTION (QUERYING IMPLANT DATE). UPDATE RECEIVED: (B)(4) 2014 - AMENDED IMPLANT DATE: (B)(6) 2005 AND AMENDED REVISION DATE: (B)(6) 2011. UPDATE RECEIVED: (B)(4) 2014 - FILE HANDLER ADVISED HOSPITAL HAVE LOST ALL DETAILS OF LOT NUMBERS AND PRODUCT CODES, SO UNABLE TO REQUEST ANY FURTHER DETAILS - PLEASE SEE ATTACHED DOCUMENT. UPDATE (B)(6) 2017: CLAIM LETTER, ASR SNAPSHOT, AND RECONCILIATION PATIENT NAME RECEIVED. ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON: (B)(6) 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

    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- (B)(4). 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

    ASR REVISION;ASR XL - LEFT HIP;REASON(S) FOR REVISION: PAIN; 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 - LEFT; REASON(S) FOR REVISION: PAIN AND ALVAL / SOFT TISSUE REACTION. (QUERYING IMPLANT DATE). UPDATE RECEIVED: (B)(4) 2014 - AMENDED IMPLANT DATE: (B)(4) 2005 AND AMENDED REVISION DATE: (B)(4) 2011. UPDATE RECEIVED: (B)(4) 2014 - FILE HANDLER ADVISED HOSPITAL HAVE LOST ALL DETAILS OF LOT NUMBERS AND PRODUCT CODES, SO UNABLE TO REQUEST ANY FURTHER DETAILS.

    Description of Event or Problem · 1

    UPDATE JUL 24, 2017: CLAIM LETTER, ASR SNAPSHOT, AND RECONCILIATION PATIENT NAME RECEIVED. ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON: SEP 8, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173580 UNIDENTIFIED ASR CUP HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention