BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 47

    MDR report key: 4800441 · Received May 27, 2015

    Report

    Report Number
    1818910-2015-21959
    Event Type
    Injury
    Date Received
    May 27, 2015
    Date of Event
    May 28, 2009
    Report Date
    May 6, 2015
    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

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN 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 THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. (B)(4).

    Additional Manufacturer Narrative · 1

    ASR REVISION, ASR RESURFACING- RIGHT, REASON(S) FOR REVISION: UNKNOWN, PATIENT IS RESURFACING TO XL - CUP AND HEADS (RESURFACING AND XL) PRODUCT DETAILS REC'D THIS COM IS FOR RESURFACING REVISION OF HEAD ONLY (CUP REMAINED IN SITU)- SEE COM (B)(4) FOR XL REVISION THE RESURFACING PRODUCTS: 9998-04-754 (B)(4) AND 9998-04-047 (B)(4) WERE IMPLANTED (B)(6) 2008 THE HEAD WAS THEN REVISED ON (B)(6)2009 TO AN XL HEAD ALONG WITH STEM AND TAPER SLEEVE (DETAILS NOT PROVIDED) THESE PRODUCTS, ALONG WITH THE CUP 9998-04-754 (B)(4) FROM THE RESURFACING IMPLANT, WERE THEN REVISED (B)(6) 2010. BOTH REVISIONS WERE PERFORMED AT(B)(4)BY(B)(4) ACCORDING TO UPDATED CLAIMSUITE. THIS CLAIMSUTE WAS ORIGINALLY REC'D ON 8 APR 2015. HOWEVER, AS I HAVE HAD TO REQUEST FURTHER INFORMATION TO DETERMINE WHAT HAPPENED IN EACH REVISION I HAVE STATED THE ALERT DATE 6TH MAY 2015 AS THIS WAS THE DATE OF MY FINAL REQUEST. ALL REQUESTS HAVE BEEN ADDED TO THIS COM AND WILL ALSO BE ATTACHED TO COM (B)(4). SM 27 MAY 2015 UPDATE JUL 24, 2017: CLAIM LETTER RECEIVED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATE ON: SEP 08, 2017. 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: UNKNOWN. PATIENT IS RESURFACING TO XL - CUP AND HEADS (RESURFACING AND XL) PRODUCT DETAILS REC'D THIS COM IS FOR RESURFACING REVISION OF HEAD ONLY (CUP REMAINED IN SITU)- SEE (B)(4) FOR XL REVISION. THE RESURFACING PRODUCTS: 9998-04-754 ((B)(4)) AND 9998-04-047 ((B)(4)) WERE IMPLANTED (B)(6) 2008 THE HEAD WAS THEN REVISED ON (B)(6) 2009 TO AN XL HEAD ALONG WITH STEM AND TAPER SLEEVE (DETAILS NOT PROVIDED). THESE PRODUCTS, ALONG WITH THE CUP 9998-04-754 ((B)(4)) FROM THE RESURFACING IMPLANT, WERE THEN REVISED (B)(6) 2010. BOTH REVISIONS WERE PERFORMED AT (B)(6) BY (B)(6) ACCORDING TO UPDATED (B)(6). THIS (B)(6) WAS ORIGINALLY REC'D ON 8 APR 2015. HOWEVER, AS I HAVE HAD TO REQUEST FURTHER INFORMATION TO DETERMINE WHAT HAPPENED IN EACH REVISION I HAVE STATED THE ALERT DATE 6TH MAY 2015 AS THIS WAS THE DATE OF MY FINAL REQUEST. ALL REQUESTS HAVE BEEN ADDED TO THIS COM AND WILL ALSO BE ATTACHED TO (B)(4).

    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 UPDATE ON: SEP 08, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341610 TOTAL ASR FEM IMP SIZE 47 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD - 8010379 2464135

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention