BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9/10 COCR HEAD 32MM +0

    MDR report key: 9907644 · Received March 31, 2020

    Report

    Report Number
    1818910-2020-09790
    Event Type
    Injury
    Date Received
    March 31, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 2, 2020
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). INVESTIGATION SUMMARY: THE PRODUCTS WERE RETURNED FOR REVIEW. IT WAS NOTED THAT A DEPUY STEM AND HEAD WERE USED WITH A COMPETITORS LINER AND CUP. THIS IS REPRESENTATIVE OF OFF LABEL USE. THE DETAILS OF THE CUP AND LINER ARE NOT GIVEN AS PART OF THIS COMPLAINT. THE HEAD AND STEM TAPER ARE BOTH DISCOLORED. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. THE PRODUCTS SHALL BE RETAINED FOR FUTURE REFERENCE UNLESS SPECIFICALLY REQUESTED BACK BY THE COMPLAINANT. THE COMPLAINT WAS RECEIVED INTO THE COMPANY WITH THE FOLLOWING COMMENT: THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2010 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE HEAD (P/N: 152190062), THE STEM (P/N: 900550210) AND THE LINER (LINER AND CUP WERE MANUFACTURED BY STRYKER) DUE TO OSTEOLYSIS OF THE FEMUR, LOOSENING OF THE STEM, SUSPECTED ARMD. AS AN INTRAOPERATIVE PATHOLOGICAL EXAMINATION, THERE WAS NO INFECTION, NOR NO WEAR OF THE LINER, HOWEVER IT WAS CONFIRMED THAT THERE WAS WEAR DEBRIS AT THE HEAD-NECK JUNCTION. OSFERION (ARTIFICIAL BONE) WAS USED FOR BONE DEFECT AT THE FEMUR AND MEDIAL GREATER TROCHANTER. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THE HEAD AND STEM WERE RETURNED FOR REVIEW. IT MUST BE NOTED THAT THE LINER AND CUP WERE A COMPETITORS PRODUCTS. THE RETURNED PRODUCTS WERE: (1) 9/10 COCR HEAD 32MM +0 , PRODUCT CODE: 152190062, LOT: 2362277. (1) SROM 9/10 16X11X130 30+4, PRODUCT CODE: 900550210, LOT: UNKNOWN. A WORLDWIDE COMPLAINT SEARCH FOR THE HEAD DETAILS IDENTIFIED NO PREVIOUS COMPLAINTS FOR THAT PRODUCT LOT COMBINATION. THE STEM LOT NUMBER WAS GIVEN AS 0645636 BUT WAS UNABLE TO BE CONFIRMED AS A VALID LOT NUMBER. THE PRODUCTS WERE PHOTOGRAPHED AND THE IMAGES PASSED ON TO BIO ENGINEERING FOR REVIEW. THE BIO ENGINEERING REPORT SUMMARISED: PLEASE NOTE AT THE TIME OF THE REVIEW 26TH MARCH 2020, THE VISUAL INSPECTION WAS CARRIED OUT THROUGH IMAGES OF THE COMPLAINT TAKEN BY THE COMPLAINT ANALYST. PER THE COMPLAINT DESCRIPTION IT STATES THAT "IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE HEAD (P/N: 152190062), THE STEM (P/N: 900550210) AND THE LINER (LINER AND CUP WERE MANUFACTURED BY STRYKER)." THIS IS REPRESENTATIVE OF OFF LABEL USE. THE DETAILS OF THE CUP AND LINER ARE NOT GIVEN AS PART OF THIS COMPLAINT. THE HEAD AND STEM TAPER ARE BOTH DISCOLORED. THE FULL REPORT IS ATTACHED TO THE COMPLAINT FOR FURTHER DETAILS. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. THE PRODUCTS SHALL BE RETAINED FOR FUTURE REFERENCE UNLESS SPECIFICALLY REQUESTED BACK BY THE COMPLAINANT. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL.

    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE REPORTED IS SIMILAR TO FDA PRODUCT CODE: JDI.

    Description of Event or Problem · 1

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2010 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE HEAD (P/N: 152190062), THE STEM (P/N: 900550210) AND THE LINER (LINER AND CUP WERE MANUFACTURED BY STRYKER) DUE TO OSTEOLYSIS OF THE FEMUR, LOOSENING OF THE STEM, SUSPECTED ARMD. AS AN INTRAOPERATIVE PATHOLOGICAL EXAMINATION, THERE WAS NO INFECTION, NOR NO WEAR OF THE LINER, HOWEVER IT WAS CONFIRMED THAT THERE WAS WEAR DEBRIS AT THE HEAD-NECK JUNCTION. OSFERION (ARTIFICIAL BONE) WAS USED FOR BONE DEFECT AT THE FEMUR AND MEDIAL GREATER TROCHANTER. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368748 9/10 COCR HEAD 32MM +0 SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS JDI DEPUY INTERNATIONAL LTD - 8010379 2362277

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 9/10 COCR HEAD 32MM +0| COMPETITOR| COMPETITOR| SROM 9/10 16X11X130 30+4