BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPT TYPE 1 TPR SLEVE 0MM

    MDR report key: 9636041 · Received January 28, 2020

    Report

    Report Number
    3002806535-2020-00056
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    December 19, 2019
    Report Date
    May 28, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: MEDICAL PRODUCT: CER BIOLOXD OPTION HD 36MM, CATALOG #: 650-1057, LOT #: 2934973. MEDICAL PRODUCT: REGEN/RNGLC+ LTD 56MM SZ 24, CATALOG #: PT-116056, LOT #: 240160. MEDICAL PRODUCT: G7 APICAL HOLE PLUG, CATALOG #: 010000994, LOT #: 6102385. MEDICAL PRODUCT: TPRLC 133 MP T1 PPS SO 8X101MM, CATALOG #: 51-108080, LOT #: 6006745. MEDICAL PRODUCT: TI LOW PROFILE SCREW 6.5X25MM, CATALOG #: 103532, LOT #: 181420. MEDICAL PRODUCT: RINGLOC+ REPLACEMENT RING SZ24, CATALOG #: 106024, LOT #: 304650. MEDICAL PRODUCT: EPOLY RLC 36MM 10DEG SZ24, CATALOG #: EP-105894, LOT #: 842180. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00055-1. 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. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. THE STERILISATION CERTIFICATES WERE REVIEWED AND CONFIRMED THAT PRODUCT IS STERILISED WITHIN THE SPECIFICATION RANGE. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 5 SIMILAR COMPLAINTS FOR THIS ITEM CODE 650-1057 AND NO SIMILAR COMPLAINTS FOUND FOR THE ITEM CODE 650-1066. THERE WERE TRENDS IDENTIFIED FROM THE COMPLAINT HISTORY REVIEW; FOR THE ITEM 650-1057, THE SIMILAR COMPLAINTS (B)(4) AND (B)(4) ARE HAVING THE SAME LOT NUMBER #2955098 AND (B)(6). THERE ARE NO TRENDS IN THE CAUSE; IN MOST OF THE SIMILAR COMPLAINTS, CAUSE COULD NOT BE ESTABLISHED. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: THE EVENT REPORTS REVISION DUE TO INFECTION. RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLE COULD NOT BE SELECTED FOR COMPARISON. IN THE RISK FILE, INFECTION IS CONSIDERED HARM WITH A SEVERITY LEVEL OF 3 FOR A NUMBER OF HAZARDS DEFINED AS MODERATE, WHICH IS DESCRIBED IN THE SEVERITY TABLE AS: S-3 PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THEREFORE, THE REPORTED EVENT IS IN LINE WITH THE SEVERITY AS DOCUMENTED IN THE RMR. CORRECTIVE ACTION TAKEN: NO CORRECTIVE ACTION REQUIRED AT THIS TIME. PREVENTIVE ACTION TAKEN: NO PREVENTIVE ACTION REQUIRED AT THIS TIME. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. H3 OTHER TEXT : PRODUCT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT HIP REVISION FOR UNKNOWN REASONS. SUBSEQUENTLY, THE PATIENT UNDERWENT ANOTHER REVISION DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A CEMENT SPACER IMPLANTED. THIS COMPLAINT IS REPORTING THE REVISION DUE TO INFECTION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER,NONE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI# (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: CER BIOLOXD OPTION HD 36MM, CATALOG #: 650-1057, LOT #: 2934973, MEDICAL PRODUCT: REGEN/RNGLC+ LTD 56MM SZ 24, CATALOG #: PT-116056, LOT #: 240160, MEDICAL PRODUCT: G7 APICAL HOLE PLUG, CATALOG #: 010000994, LOT #: 6102385 MEDICAL PRODUCT: TPRLC 133 MP T1 PPS SO 8X101MM, CATALOG #: 51-108080, LOT #: 6006745, MEDICAL PRODUCT: TI LOW PROFILE SCREW 6.5X25MM, CATALOG #: 103532, LOT #: 181420, MEDICAL PRODUCT: RINGLOC+ REPLACEMENT RING SZ24, CATALOG #: 106024, LOT #: 304650, MEDICAL PRODUCT: EPOLY RLC 36MM 10DEG SZ24, CATALOG #: EP-105894, LOT #: 842180. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00055. 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 RIGHT HIP REVISION FOR UNKNOWN REASONS. SUBSEQUENTLY, THE PATIENT UNDERWENT ANOTHER REVISION DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A CEMENT SPACER IMPLANTED. THIS COMPLAINT IS REPORTING THE REVISION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101445 CER OPT TYPE 1 TPR SLEVE 0MM HIP ARTHROPLASTY LZO BIOMET UK LTD. N/A 2920992

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R