BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/GRIPTION 50MM

    MDR report key: 9409779 · Received December 4, 2019

    Report

    Report Number
    1818910-2019-120096
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    July 26, 2016
    Report Date
    October 14, 2016
    Product Code
    LPH
    UDI-DI
    10603295010296
    PMA / PMN Number
    K071784
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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. THE ACETABULAR CUP APPEARS TO HAVE BOTH MORE ABDUCTION AND LESS VERSION ANGLE THAN WOULD BE RECOMMENDED BY DEPUY. CUP POSITION IS DETERMINED BY THE IMPLANTING SURGEON AND IS NOT CONSIDERED A PRODUCT PROBLEM. 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

    (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
    1208019 PINN SECTOR W/GRIPTION 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH 1217-32-050 EA5DW1000 10603295010296

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention