BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RLOC-X ARCOMXL H/W 46/28MM 22

    MDR report key: 10858807 · Received November 18, 2020

    Report

    Report Number
    3002806535-2020-00484
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 17, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM XL-052846. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THESE ITEM AND LOT COMBINATION. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: -RISK MANAGEMENT FILES DOCUMENT 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 TABLES COULD NOT BE SELECTED FOR COMPARISON. -THE REPORTED EVENT STATES SNAP RING OUT OF CUP CANNOT BE REMOVED AND LINER HAS A 2MM FRETTING AMPLITUDE. -THIS HAZARD (LOCKING RING GROOVE WITHIN ACETABULAR LINER TOO SMALL FOR LOCKING RING) HAS A SEVERITY OF 2 WHICH IS DEFINED IN THE SEVERITY TABLE AS: 2:MINOR - ILLNESS OR INJURY THAT DOES NOT REQUIRE PRESCRIBED MEDICAL OR SURGICAL INTERVENTIONS. -THE OUTCOME OF THIS COMPLAINT IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMR. IN ORDER TO CALCULATE THE OCCURRENCE RATE, SALES AND COMPLAINT DATA FOR THIS ITEM NUMBER HAVE BEEN OBTAINED, AND ARE ATTACHED FOR A PERIOD OF THE LAST 3 YEARS PRIOR TO NOTIFICATION DATE, BEING OCT 2020. SALES (OCT 2017 ¿ OCT 2020) = (B)(4) UNITS. COMPLAINTS SEARCH WAS CONDUCTED FOR EVENTS OCCURRING BETWEEN OCT 2017 ¿ OCT 2020 FOR ITEM XL-052846. THERE ARE NO FURTHER COMPLAINTS IDENTIFIED FOR THIS ITEM NUMBER OTHER THAN CMP-0640912. THEREFORE, THE CALCULATED OCCURRENCE RATE IS 1 IN (B)(4). OCCURRENCE CALCULATION = 3: OCCASIONAL 1:10,000 < P < 1:1,000. - RMF ESTIMATES = 1: IMPROBABLE <1:100,000. SINCE THE OCCURRENCE CALCULATION IS BASED ON ONLY 1 COMPLAINT, THE CURRENT OCCURRENCE RATINGS IN THE RISK MANAGEMENT FILE ARE STILL RELEVANT AND HAVE NOT BEEN EXCEEDED; AS IT IS NOT POSSIBLE TO MAKE A CALCULATION BASED ON ONE INSTANCE OF A COMPLAINT. THE FAILURE MODE WILL BE MONITORED THROUGH ZIMMER BIOMET INTERNAL COMPLAINT AND POST MARKET SURVEILLANCE ACTIVITIES WITH FURTHER REVIEW OF RISK CONDUCTED THROUGH THESE PROCESSES. 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

    ON (B)(6) 2020, A TOTAL HIP SURGERY OF A U-CUP +ARCOM XL LINER + BIOLOX DELTA FEMORAL HEAD +TAPERLOC LONG HANDLE OF BONMEI PRODUCT LINE WAS PERFORMED. SIZES: CUP SIZE: 48MM; LINING SIZE: 22; FEMORAL HEAD SIZE: 28; FEMORAL HANDLE SIZE:11. IT WAS REPORTED THAT DURING THE SURGERY THE EXTERNAL CUP IN THE ACETABULUM WAS VERY SOLID INSIDE THE ACETABULUM, THEREFORE, THE SNAP RING COULD NOT BE REMOVED. IT WAS ALSO NOTED THAT AFTER THE ARCOM XL LINER WAS FITTED, THE LINER HAD A LARGE AMOUNT OF FRETTING, ABOUT 2MM. THE OPERATION COMPLETED WITHOUT REMOVING THE CUP AND THE LINING. 31-60 MINUTES DELAY OF THE SURGERY. NO HARM OF THE PATIENT, OR THE USER REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: TPRLC 133 T1 PPS SO 11X142 MM, CATALOG #: 51-103110, LOT #: 6656965. MEDICAL PRODUCT: DELTA CER FEM HD 28/0 MM T1, CATALOG #: 650-1158, LOT #: 2019100479. ADDRESS: (B)(6) THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A TOTAL HIP SURGERY OF A U-CUP +ARCOM XL LINER + BIOLOX DELTA FEMORAL HEAD +TAPERLOC LONG HANDLE OF BONMEI PRODUCT LINE WAS PERFORMED. SIZES: CUP SIZE: 48 MM, LINING SIZE: 22, FEMORAL HEAD SIZE: 28, FEMORAL HANDLE SIZE:11. IT WAS REPORTED THAT DURING THE SURGERY THE EXTERNAL CUP IN THE ACETABULUM WAS VERY SOLID INSIDE THE ACETABULUM, THEREFORE, THE SNAP RING COULD NOT BE REMOVED. IT WAS ALSO NOTED THAT AFTER THE ARCOM XL LINER WAS FITTED, THE LINER HAD A LARGE AMOUNT OF FRETTING, ABOUT 2 MM. THE OPERATION COMPLETED WITHOUT REMOVING THE CUP AND THE LINING. 31-60 MINUTES DELAY OF THE SURGERY. NO HARM OF THE PATIENT, OR THE USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327864 RLOC-X ARCOMXL H/W 46/28MM 22 NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER LPH BIOMET UK LTD. N/A 6484793

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR