BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN BIOLOX DELTA HEAD

    MDR report key: 15848092 · Received November 22, 2022

    Report

    Report Number
    9614209-2022-00124
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    November 4, 2022
    Report Date
    January 31, 2023
    Manufacturer
    CORIN LTD (UK & FR)
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CASE-2022-0032 INITIAL REPORT ADDITIONAL INFORMATION INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES, PATIENT ACTIVITY LEVEL AND WEIGHT, PATIENT MEDICAL HISTORY, WHETHER THE PATIENT FOLLOWED CORRECT POST-OP PROTOCOL, WHETHER THE PATIENT EXPERIENCED ANY SLIPS / FALLS OR OTHER TRAUMA POST PRIMARY SURGERY, AND AN UPDATE ON THE PATIENT POST REVISION HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    (B)(4)- FINAL REPORT. ADDITIONAL INFORMATION INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES, PATIENT ACTIVITY LEVEL AND WEIGHT, PATIENT MEDICAL HISTORY, WHETHER THE PATIENT FOLLOWED CORRECT POST-OP PROTOCOL, WHETHER THE PATIENT EXPERIENCED ANY SLIPS / FALLS OR OTHER TRAUMA POST PRIMARY SURGERY, AND AN UPDATE ON THE PATIENT POST REVISION HAS BEEN REQUESTED. HOWEVER, WE ONLY KNOW THAT THE PATIENT DID NOT EXPERIENCED ANY TRAUMA AND IS REPORTED TO BE DOING WELL POST OP. THE OTHER INFORMATION COULD NOT BE PROVIDED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED, AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. THESE DEVICES WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THE ABOVE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AND THE ROOT CAUSE CANNOT BE DETERMINED. THEREFORE, THIS CASE IS NOW CONSIDERED CLOSED. HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED, THIS CASE MAY BE RE-OPENED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    RIGHT SIDE REVISION HIP SURGERY DUE TO BONE FRACTURE FROM STEM SUBSIDENCE. A SIZE 7 COLLARED PARAGON HIP STEM SUBSIDED AND A FRACTURE HAD OCCURRED AS A RESULT OF THIS. ATTEMPTED TO REMOVE THE STEM BUT IT WAS HIGHLY FIXATED, THEREFORE COMPENSATED FOR THE SUBSIDENCE BY CHANGING THE HEAD. HEAD IMPLANT REMOVED AND REPLACED. STEM, CUP AND LINER IMPLANTS REMAIN IN-SITU. PATIENT IS AN 80 Y/O MALE WITH UNKNOWN WEIGHT AND ACTIVITY LEVELS. PRODUCT INFO: #1 TRINITY BIOLOX DELTA MOD HEAD 036MM MEDIUM 0 (EXPLANTED), PART NO. - 104.3605, LOT NO. - 494521. #2 PARAGON STEM HIGH OFFSET COLLARED PCHA SIZE 7 (IN-SITU), PART NO. - GM08001-203-07, LOT NO. - 467043. #3 TRINITY CUP 56MM TAPER SIZE 4 (IN-SITU), PART NO. - 321.04.356, LOT NO. - 488710. #4 TRINITY ECIMA LINER SIZE 4 036MM NEUTRAL OFFSET (IN-SITU), PART NO. - 322.04.636, LOT NO. - 494705.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247605 CORIN BIOLOX DELTA HEAD BIOLOX DELTA CERAMIC HEAD LZO CORIN LTD (UK & FR) 104.3605 494521

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| H TRINITY CUP: 321.04.356, 488710| TRINITY ECIMA LINER: 322.04.636, 494705