BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 45

    MDR report key: 7926971 · Received October 2, 2018

    Report

    Report Number
    1818910-2018-71063
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    January 12, 2015
    Report Date
    September 3, 2018
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO PMA/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. CONCOMITANT MEDICAL PRODUCTS: TOTAL ASR FEM IMP SIZE 45 FEMORAL HEAD; ASR ACETABULAR IMPLANT 50 ACETABULAR CUP.

    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.

    Additional Manufacturer Narrative · 1

    (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

    COMPLAINT DESCRIPTION: ASR REVISION; RIGHT, RESURFACING. REASON(S) FOR REVISION: UNKNOWN. UPDATE AD 03 SEP 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO SCF (SURGEON CONFIRMATION FORM). SCF ALLEGES COMPONENT LOOSENING, PAIN, COMPONENT MALALIGNMENT, ALVAL AND SOFT TISSUE REACTION. CORRECTED LOT NUMBER OF THE CUP FROM 1184621 TO 2571435 AND HEAD FROM 1851463 TO 2565516 AND MANUFACTURING DATE OF CUP AND HEAD. UPDATE PATIENT HARM OF ALL IP'S. DOI: (B)(6) 2008; DOR: (B)(6) 2015; RIGHT HIP.

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE FEMORAL HEAD WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766528 TOTAL ASR FEM IMP SIZE 45 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS KXA DEPUY INTERNATIONAL LTD. 8010379 2565516

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention