BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 36MM

    MDR report key: 10377892 · Received August 7, 2020

    Report

    Report Number
    3002806535-2020-00365
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    May 10, 2019
    Report Date
    September 25, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. RADIOGRAPHS: ONE ANTEROPOSTERIOR (AP) RADIOGRAPH OF THE RIGHT HIP WAS PROVIDED FOR ANALYSIS WITH (B)(4). THE X-RAY SHOWS A FRACTURED STEM TRUNNION DISLOCATED FROM THE METAL HEAD, WHICH WAS THE REASON FOR A SECOND REVISION SURGERY ON (B)(6) 2020. THIS ISSUE HAS BEEN ADDRESSED AS PART OF (B)(4), AND THEREFORE THIS X-RAY WILL NOT BE ASSESSED IN THIS REPORT. IN THE ADVERSE EVENT REPORTED IN (B)(4)- I.E. THE FIRST REVISION SURGERY ON (B)(6) 2019, PERFORMED 3 DAYS AFTER PRIMARY SURGERY ¿ THE HEAD AND LINER WERE REMOVED AND REPLACED. THIS REFERS TO A Ø36 MM BIOLOX DELTA OPTION FEMORAL HEAD (PART NO. 650-1057, UK PRODUCT) AND A LONGEVITY ACETABULAR LINER, NEUTRAL, 58 LL X 36 MM (PART NO. 00-8751-013-36, US PRODUCT). THE LINER HAS BEEN ASSESSED AS PART OF (B)(4). THE REVISED FEMORAL HEAD HAS NOT BEEN RECEIVED FOR ANALYSIS. POST-PRIMARY AND POST-REVISION SURGERY (I.E. FIRST REVISION SURGERY) X-RAYS HAVE NOT BEEN PROVIDED WITH (B)(4). PATIENT DETAILS SUCH AS HEIGHT, WEIGHT AND ACTIVITY LEVEL, OR SURGICAL NOTES HAVE NOT BEEN PROVIDED, APART FROM A STATEMENT ABOUT THERE BEING NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. X-RAYS AND PATIENT INFORMATION HAVE BEEN REQUESTED THREE TIMES BY THE COMPLAINT HANDLING CO-ORDINATOR BUT HAVE NOT BEEN RECEIVED AT THE TIME OF WRITING THIS ACTION ITEM (NO FURTHER INFORMATION AVAILABLE). IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE UNKNOWN ISSUE THAT LED TO THE REVISION OF THE BIOLOX DELTA OPTION FEMORAL HEAD AND LONGEVITY ACETABULAR LINER ON 10 MAY 2019 WITH THE AVAILABLE INFORMATION. THE MANUFACTURING HISTORY RECORD (MHR) AND CERAMTEC INSPECTION CERTIFICATE FOR THE BIOLOX DELTA OPTION FEMORAL HEAD HAVE BEEN CHECKED AND VERIFY THAT THE COMPONENT WAS MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH ITEM AND LOT COMBINATION. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 1 SIMILAR COMPLAINT REPORTED WITH THE ITEM 650-1057. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: THE EVENT REPORTS REVISION DUE TO UNKNOWN REASON. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. AT THIS TIME, NO RISK ASSESSMENT CAN BE CONDUCTED SINCE THE HARM OR REASON FOR REVISION HAS NOT BEEN BE REPORTED. IF FURTHER INFORMATION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT OR REASON FOR REVISION ARE PROVIDED, THE RISK WILL BE RE-ASSESSED. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASON WAS PERFORMED. HEAD AND LINER WERE REMOVED AND REPLACED (ACCORDING TO THE PO).

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION (PRODUCT LOCATION UNKNOWN). CONCOMITANT MEDICAL DEVICES: MEDICAL PRODUCT: POR ST/TM CP/XL LN/CER HD, CATALOG #: 98-0001-250-03, LOT #: 98000125003; MEDICAL PRODUCT: TPRLC 133 T1 PPS SO 15X150MM, CATALOG #: 51-103150, LOT #: 6391161; MEDICAL PRODUCT: CER OPT TYPE 1 TPR SLEVE 0MM, CATALOG #: 650-1066, LOT #: 2964357; MEDICAL PRODUCT: CONTINUUM TM SHELL CLUST 58 LL, CATALOG #: 00-8757-058-01, LOT #: 64165543; MEDICAL PRODUCT: TRILOGY BONE SCR 6.5X25, CATALOG #: 00-6250-065-25, LOT #: 64381044; MEDICAL PRODUCT: HXPE LINER NEUT 58 LL X 36, CATALOG #: 00-8751-013-36, LOT #: 64165978. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO UNKNOWN REASON WAS PERFORMED. HEAD AND LINER WERE REMOVED AND REPLACED (ACCORDING TO THE PO) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842936 CER BIOLOXD OPTION HD 36MM CERAMIC FEMORAL HEAD PROSTHESIS LPH BIOMET UK LTD. N/A 2957966

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R