BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18B-SML

    MDR report key: 9409781 · Received December 4, 2019

    Report

    Report Number
    1818910-2019-120095
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    July 26, 2016
    Report Date
    October 14, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295170631
    PMA / PMN Number
    K934412
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: INVESTIGATIVE UPDATE: 29 / OCT / 2021. X-RAY IMAGES HAVE BEEN PROVIDED FOR REVIEW. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. X-RAY IMAGES HAVE BEEN PROVIDED FOR REVIEW. NONE OF THE ALLEGATIONS REPORTED REGARDING THE FEMORAL SLEEVE COMPONENT CAN BE VERIFIED. NOTHING INDICATIVE OF A PRODUCT PROBLEM IS IDENTIFIED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MATERIAL, MANUFACTURING, INSPECTION OR STERILE PROCESSING THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (B)(4). 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

    PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED ON (B)(6) 2016. THE PFS INDICATED THE PATIENT WAS REVISED FOR DISLOCATION AND A FRACTURED STEM. THE STEM HAS ALREADY BEEN REPORTED ON (B)(4). PART/ LOT HASN'T BEEN PROVIDED AT THIS TIME. PPF HAS NO NEW ALLEGATIONS REPORTED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO PERFORM AN EXCISIONAL IRRIGATION AND DEBRIDEMENT AS WELL AS AN EXTENDED TROCHANTERIC OSTEOTOMY OF THE HIP TO ADDRESS DISLOCATION, EXTENSIVE METALLOSIS AND DAMAGED TRUNNION OF THE FEMORAL COMPONENT. UPDATED THE IMPLANT DATE OF THE HEAD AND THE DETAILS OF THE IMPACTED PRODUCTS. DOI: (B)(6) 2015 (HEAD), DOI: (B)(6) 2016 (LINER), DOR: (B)(6) 2016 (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208415 S-ROM*SLEEVE PRX ZTT, 18B-SML S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE LPH DEPUY ORTHOPAEDICS INC US 52-1483 2931505 10603295170631

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Required Intervention