BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 53

    MDR report key: 7319898 · Received March 7, 2018

    Report

    Report Number
    1818910-2018-54664
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    February 10, 2018
    Report Date
    February 10, 2018
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # :(B)(4). INVESTIGATION SUMMARY:THIS HIP REPLACEMENT PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET AND THE PRODUCT CODES ARE NOW CONSIDERED INACTIVE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2018, DR. (B)(6) INFORMED US THAT HE HAD A PATIENT REPORT TO THE HOSPITAL WITH PAIN IN HIS LEFT HIP. THE PAIN WAS SAID TO BEGIN 6-12 MONTHS AGO. UPON X-RAY, DR. (B)(6) FOUND THAT THE PATIENT HAD A TOTAL HIP REPLACEMENT IN SITU (RECALLED ASR SHELL AND FEMORAL HEAD, WITH A TRILOCK FEMORAL STEM). THERE WAS CLEAR ASEPTIC LOOSENING OF THE ACETABULAR SHELL AS IT WAS NO LONGER FIXED TO BONE AND WAS SEVERELY ABDUCTED COMPARED TO THE SHELL POSITION FROM PREVIOUS X-RAYS. THE PATIENT ALSO HAD A NOTICEABLE BULGE ON HIS LEFT HIP. DR. (B)(6) INFORMED US THAT HE IS PLANNING TO REMOVE THE ASR SHELL AND FEMORAL HEAD AND REPLACE WITH A PINNACLE CUP, ALTRX POLY LINER AND A 36MM METAL 12/14 TAPER HEAD (ASSUMING THE TRUNNION OF THE TRILOCK STEM WAS IN FAIR CONDITION). DURING SURGERY, DR. (B)(6) REMOVED A LARGE AMOUNT OF BLACK METAL DEBRIS FROM THE JOINT SPACE AND CLEARED OUT ANY DETERIORATING TISSUE. HE EXPLANTED THE SHELL AND FEMORAL HEAD AND THE SCRUB NURSE PUT THEM ASIDE, SO THAT I COULD RETAIN THEM FOR CST SUBMISSION. DR. (B)(6) WENT ON TO REAM THE ACETABULUM AND IMPLANT A PINNACLE SIZE 64MM CUP AND 36X64MM NEUTRAL ALTRX LINER. UPON TRIALING WITH TRIAL FEMORAL HEADS, HE CHOSE A 36+12MM METAL FEMORAL HEAD. HE WAS HAPPY WITH OFFSET AND LENGTH AND WASHED OUT THE JOINT BEFORE CLOSING. THE ORIGINAL TOTAL HIP REPLACEMENT WAS PERFORMED IN 2009, PRIOR TO ASR BEING RECALLED. THE INFORMATION I WAS ABLE TO RETAIN FROM LOOKING AT THE SHELL AND FEMORAL HEAD ARE: SHELL (SIZE 60MM, DP 2516079 C). HEAD (LOT# 2223379, 9998901530). WHEN ATTEMPTING TO INPUT THE ACETABULAR SHELL INTO "PRODUCT DETAILS", I'M UNABLE TO SELECT A PRODUCT WITH THE INFORMATION I FOUND ON THE ACETABULAR SHELL ((B)(4)). PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163293 DEPUY ASR XL FEM IMP SIZE 53 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS KWA DEPUY INTERNATIONAL LTD. 8010379 2223379

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention