BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMA HI OFFSET R SZ 4

    MDR report key: 4090774 · Received September 15, 2014

    Report

    Report Number
    1818910-2014-28045
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    November 30, 2011
    Report Date
    November 28, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    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

    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. 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

    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.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION, ASR XL - UNKNOWN HIP. REASON FOR REVISION: COMPONENT LOOSENING & METAL REACTION. (B)(4). UPDATE: AMENDED ORIGINAL SURGERY DATE, ADDED SIDE HIP TO BE REVISED, ADDED SURGEON NAME AND FURTHER REASON FOR REVISION. RECEIVED: (B)(6) 2012. HIP(S) TO BE REVISED: RIGHT. REASON(S) FOR REVISION: COMPONENT LOOSENING (CUP, STEM AND HEAD) AND METAL REACTION AND PAIN. UPDATE RECEIVED (B)(6) 2014. ADDITIONAL HOSPITAL AND SURGEON ADDED. STATUS AMENDED TO "LEGAL". KID NUMBER ADDED. SURGERY DATE AMENDED IN LINE WITH (B)(6) MEDICAL AUTHORITY INCIDENT REPORT. UPDATE RECEIVED (B)(6) 2014. BOTH FEMORAL HEAD AND CUP ARE CONFIRMED TO HAVE BEEN LOOSENED. QUERY RESPONSE RECEIVED (B)(6) 2014. STEM WAS ALSO LOOSENED.

    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 - UNKNOWN HIP. REASON FOR REVISION: COMPONENT LOOSENING & METAL REACTION. (B)(4). UPDATE: AMENDED ORIGINAL SURGERY DATE, ADDED SIDE HIP TO BE REVISED, ADDED SURGEON NAME AND FURTHER REASON FOR REVISION. RECEIVED: NOVEMBER 15TH 2012. HIP(S) TO BE REVISED: RIGHT REASON(S) FOR REVISION: COMPONENT LOOSENING (CUP, STEM AND HEAD) & METAL REACTION AND PAIN. ***UPDATE RECEIVED 4TH AUGUST 2014. ADDITIONAL HOSPITAL AND SURGEON ADDED. STATUS AMENDED TO "LEGAL". KID NUMBER ADDED. SURGERY DATE AMENDED IN LINE WITH (B)(6)*** UPDATE RECEIVED 29TH AUGUST 2014. BOTH FEMORAL HEAD AND CUP ARE CONFIRMED TO HAVE BEEN LOOSENED. QUERY RESPONSE RECEIVED 8TH SEPTEMBER 2014. STEM WAS ALSO LOOSENED. UPDATE 28 NOV 2014: REC'D LEGAL LETTER, ADDITIONAL DR, ALLEGED REASON FOR REVISION: INCREASING METAL IONS. ALSO ADDED EXPIRY DATES FOR ALL PRODUCTS. ALL UPDATES ARE ALLEGED AS SOLICITOR'S LETTER IS DERIVED FROM A TEMPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568294 PROXIMA HI OFFSET R SZ 4 HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS INC US 2213766

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention