BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 36IDX52OD

    MDR report key: 9243962 · Received October 28, 2019

    Report

    Report Number
    1818910-2019-112450
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 3, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295014577
    PMA / PMN Number
    K033273
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6 PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE THE SURGICAL INTERVENTION AND MEDICAL DEVICE REMOVAL.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE HEAD AND THE LINER WERE RETURNED FOR INVESTIGATION. THE MODE OF FAILURE OF THE PROSTHESIS IS MULTI-FACTORIAL AND, WHILE THE STEEP SHELL ABDUCTION ANGLE MAY BE A CONTRIBUTORY FACTOR, CONSIDERATION HAS TO BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS, SURGICAL PROCESS, PATIENT VARIABLES E.G. ACTIVITY, WEIGHT, BMI AND USE, ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR BOTH THE HEAD AND THE LINER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A WORLDWIDE COMPLAINT SEARCH IDENTIFIED NO PREVIOUS COMPLAINTS FOR THE LINER (121936152, LOT 8792317) BUT DID FIND ONE PREVIOUS COMPLAINT FOR THE HEAD (136553000, LOT 8793894). THE PREVIOUS HEAD COMPLAINT WAS FOR INFECTION AND NO PRODUCT DEFECT WAS NOTED AND IS NOT RELATED TO THE EVENT IN THIS COMPLAINT. THE PRODUCTS SHALL BE RETAINED FOR FUTURE REFERENCE BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE AFFECTED SIDE IS LEFT HIP.

    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

    THIS COMPLAINT IS RELATED TO A PATIENT THAT UNDERWENT TO SURGERY IN (B)(6) 2018 WITH A SECOND HIP PROSTHESIS, AFTER THE FIRST PROSTHESIS WAS IMPLANTED IN (B)(6) 2018. THE PATIENT FELT A SNAP IN A PARTICULAR MOVEMENT THAT WAS MADE A MONTH AFTER PLACING THE PROSTHESIS, THEN BEGAN TO FEEL A NOISE IN THE HIP AREA. RELATIVELY RECENTLY THE PATIENT VISITED THE SURGEON WHO PERFORMED A NEW RX AND FOUND THAT THE HIP PROSTHESIS WAS DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038682 PINN MAR +4 10D 36IDX52OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 8792317 10603295014577

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention UNKNOWN HIP FEMORAL HEAD