BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 36IDX56OD

    MDR report key: 11968604 · Received June 9, 2021

    Report

    Report Number
    1818910-2021-12253
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    May 24, 2021
    Report Date
    May 24, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295014591
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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 MANUFACTURING OR MATERIAL 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). 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

    IT WAS REPORTED THAT THE PATIENT HAD HIS REPLACED 14 YEARS AGO BY ANOTHER SURGEON AT ANOTHER HOSPITAL WHICH WAS NOT KNOWN AT THE TIME I ASKED DURING SURGERY. THIS PATIENT DID WELL UNTIL RECENTLY WHERE HE CAME IN TO SEE THE SURGEON. THE X-RAYS INDICATED THE FEMORAL HEAD WAS ARTICULATING ON THE CUP. THE SURGEON AND THE PATIENT DECIDED THAT A REVISION WOULD BE DONE TO CORRECT THE ISSUE. DURING THE SURGERY THE 56MM ACETABULAR SECTOR CUP, 56MM MARATHON LINER, AND A 36MM 8.5 HIP BALL WERE EXPLANTED. THE AML STEM, LOTT AND CAT # UNKNOWN WAS LEFT IN VITRO. THE ACETABULAR LINER WAS BROKEN AND THE HIP BALL WAS RUBBING AGAINST THE ACETABULAR CUP WHICH CAUSED SIGNIFICANT DAMAGE TO THE FEMORAL HEAD AND LINER. A NEW COMPETITOR CUP WAS IMPLANTED. DOI: 14 YEARS AGO - DOR: (B)(6) 2021 (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865940 PINN MAR +4 10D 36IDX56OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 1219-36-156 DD9F81000 10603295014591

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention DELTA CER HEAD 12/14 36MM +8.5| PINN MAR +4 10D 36IDX56OD| PINNACLE SECTOR II CUP 56MM| UNKNOWN HIP FEMORAL STEM