BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18D-LRG

    MDR report key: 4943277 · Received July 27, 2015

    Report

    Report Number
    1818910-2015-26579
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    DEPUY (IRELAND) - 9616671
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    ATTORNEY

    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. (B)(4).

    Description of Event or Problem · 1

    NEW (B)(4) RECORD CREATED IN ORDER TO UPDATE (B)(4) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: ASR REVISION BI-LATERAL. HIP REPLACEMENT: ASR XL (RIGHT) ASR XL (LEFT). SURGERY DATE: (B)(6) 2008, (B)(6) 2006. DATE OF REVISION: (B)(6) 2011, (B)(6) 2010. UPDATE: CORRECTED REVISION COUNTRY. INFORMATION RECEIVED 30 APR 2012. UPDATE: ADDED ADDITIONAL REASONS FOR REVISION, PRODUCT CODES FOR SLEEVES AND STEMS RECEIVED 7 AUG 2012. REASON(S) FOR REVISION: DISCOMFORT, WORSENING MOBILITY, ELEVATED CR & CO LEVELS, EFFUSIONS, FIBROSIS IN CAPSULE, PSEUDO TUMOUR IN RIGHT HIP. ASR XL (RIGHT) 1, 2, 7, 9 AND 10: 2469353 / 2509662 / 1850830 / 2453756 / 2448276. ASR XL (LEFT) 3, 4, 5, 6 AND 8: 1831945 / 2048720 / 2464481 / 1201712 / UNKNOWN (PRODUCT -8). UPDATE RECEIVED APRIL 24TH, 2013. REASON FOR REVISION ADDED. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE 27 JULY 2015: UPDATED TO LEGAL WITH (B)(6) REF. (B)(4). THIS PATIENT HAS HAD A BILATERAL REVISION. THIS COM IS FOR THE RIGHT HIP. FOR THE LEFT HIP SEE COM (B)(4). SEPARATED PRODUCTS INTO LEFT AND RIGHT HIPS AS THE ORIGINAL DINT WAS FOR BOTH HIPS. ADDED MANUFACTURE AND EXPIRY DATES FOR ALL PRODUCTS. TAKEN FROM (B)(6) ALERT 17 JULY 2015 AND QUERY 1 REPLY 24 JULY 2015. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486108 S-ROM*SLEEVE PRX ZTT, 18D-LRG HIP FEMORAL STEM/SLEEVE LPH DEPUY (IRELAND) - 9616671 2448276

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention