BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 28IDX44OD

    MDR report key: 15418362 · Received September 14, 2022

    Report

    Report Number
    1818910-2022-17902
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 14, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295013433
    PMA / PMN Number
    K033273
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: ADDED: A2 (AGE), B5, D6A. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: H4.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR ANALYSIS. BASED IN THE VISUAL ANALYSIS OF THE PROVIDED PHOTOGRAPHIC EVIDENCE ALONG WITH EXAMINATION OF THE PART, IT WAS OBSERVED THAT A PORTION OF THE LINER'S RIM WAS FRACTURED. LOCATION OF THE FRACTURE IS CONSISTENT WITH EXCESSIVE EDGE LOADING OF THE FEMORAL HEAD AND PATIENT'S BODY WEIGHT. INTERLOCK FEATURE EDGE OF THE LINER DENOTED 3 ARD TABS SHEARED OFF FROM THE LINER WHICH IS ALSO EVIDENCE OF THE LINER HAVING DISASSOCIATED FROM THE CUP. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DRAWING/SPECIFICATIONS REVIEWED? N/A. DIMENSIONAL INSPECTION: N/A. 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. CORRECTED: H3.

    Description of Event or Problem · 0

    DISLOCATION OF POLYETHYLENE, WHEN THE HEAD CONTACTED WIHT THE CUP, PART OF THE CUP WAS ATE. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING?UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? A NWE INTERVACITION. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN. IP-01520034. DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. IP-01520035. DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. IP-01520036. DEVICE PROPERTY OF NONE. DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE AFFECTED SIDE? RIGHT HIP. B. WAS SURGERY TIME EXTENDED? NO. C. WHAT DO YOU MEAN '' PART OF THE CUP WAS ATE?'' PLEASE ELABORATE. THE PINNACLE CUP WAS EATEN FOR THE HEAD. PORT OF THE CUP DISAPPEAR.., I CAN IMAGEN THAT HAS HAPPENED FOR THE FRICTION BETWEEN METAL PART OF THE CUP AND CERAMIC HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675092 PINN MAR +4 10D 28IDX44OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 1219-28-144 HW7930 10603295013433

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Required Intervention DELTA CER HEAD 12/14 28MM +5| PINN BANTAM W/GRIPTION 44MM