BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEED ABT E1 MULLER CUP 28X48

    MDR report key: 10065163 · Received May 18, 2020

    Report

    Report Number
    3002806535-2020-00245
    Event Type
    Injury
    Date Received
    May 18, 2020
    Date of Event
    June 19, 2019
    Report Date
    June 18, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN NETHERLANDS. D11: MEDICAL PRODUCT: MLRY-HD POR FMRL 11X160MM, CATALOG #: 11-104111, LOT #: 2465666. MEDICAL PRODUCT: 28MM M2A MOD HEAD -6MM NK, CATALOG #: 11-163660, LOT #: 0000746524. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. FIVE RADIOGRAPHS WERE PROVIDED FOR ANALYSIS WITH (B)(4): TWO POST-PRIMARY ((B)(6) 2012) X-RAYS, ONE ANTEROPOSTERIOR (AP), AND ONE LATERAL; TWO AP POST-PRIMARY ((B)(6) 2012) X-RAYS, ONE OF THEM FULL-PELVIS; ONE PRE-REVISION FULL-PELVIS AP X-RAY ((B)(6) 2019). IMPLANT COMPONENTS APPEAR ADEQUATELY SIZED, AND THE INCLINATION ANGLE OF THE ACETABULAR CUP WAS MEASURED TO BE 53.6 IN THE FULL-PELVIS POST-PRIMARY X-RAY TAKEN ON (B)(6) 2012, WHICH IS HIGHER THAN THE INCLINATION ANGLE OF 45 RECOMMENDED IN THE EXCEED ABT CEMENTED CUP SURGICAL TECHNIQUE. PRIOR TO REVISION SURGERY ((B)(6) 2019), THE INCLINATION ANGLE OF THE CUP WAS 73.8. THIS CHANGE IN THE INCLINATION ANGLE IS IN AGREEMENT WITH THE REPORTED ISSUE OF LOOSENING OF THE CUP. THE ZPER STATES THAT THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED, AND THAT IT IS UNKNOWN WHETHER THERE WERE ANY CONTRIBUTING CONDITIONS RELATED TO THE EVENT. THE FEMALE PATIENT WAS 66 YEARS OLD AT THE TIME OF REVISION SURGERY. SURGICAL NOTES OF THE REVISION SURGERY (TRANSLATED FROM DUTCH IN GOOGLE TRANSLATE) MENTION THAT AFTER REMOVAL OF THE LOOSE CUP AND REAMING, IT APPEARS TO EXIST NOW IS A SEGMENTAL DEFECT FROM 12 HOURS TO 4 HOURS IN WHICH IT IS PARTLY A FRACTURE, WITH A MAXIMUM WIDTH OF 1.5 CM, WHICH SUGGESTS POOR QUALITY OF BONE STOCK IN THE ACETABULUM. INDEED, A REPORT FROM MEDICAL METRICS INC. FROM 16TH DECEMBER 2019 STATES THAT BONE QUALITY IS MILDLY OSTEOPENIC. INFORMATION SUCH AS PATIENT WEIGHT, HEIGHT AND ACTIVITY LEVEL WERE NOT AVAILABLE AT THE TIME OF WRITING THIS REPORT. IT IS NOT POSSIBLE TO DETERMINE THE PRIMARY CAUSE OF IMPLANT LOOSENING, ALTHOUGH IT IS LIKELY THAT A STEEP INCLINATION ANGLE OF THE CUP AND POOR BONE QUALITY WERE CONTRIBUTING FACTORS. REVIEW OF THE MANUFACTURING HISTORY RECORD FOR PART # EP-122848 WITH LOT 2217582 IDENTIFIED DEVIATION WITHIN THE PRODUCTION RUN .NCR 126689 OUTLINES THAT THE ORDERS WERE BEING RELEASED TO THE FLOOR WHILE ON SHORT SUPPLY OF SUBCOMPONENTS DUE TO ARRIVE DURING THE TIMEFRAME OF THE RUNS. NO UNITS WERE SCRAPPED OR REWORKED DURING THE PRODUCTION OF THIS LOT. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THESE ITEMS. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE DEVICE WITHIN 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. THE REPORTED EVENT STATES REVISION DUE TO LOOSENING. IN THE RISK FILE, LOOSENING IS CONSIDERED HARM WITH A MAXIMUM SEVERITY OF 4 FOR A NUMBER OF HAZARDS, WHICH IS DESCRIBED IN THE SEVERITY TABLE AS: S-4 RESULTS IN PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE / NECESSITATES SURGICAL INTERVENTION. THE OUTCOME OF THE REPORTED EVENT (SURGICAL INTERVENTION) IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMF. 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 THE EVENT DATE, BEING JUNE 2019. - SALES ((B)(6) 2016 TO (B)(6) 2019) = (B)(4). - COMPLAINTS SEARCH WAS CONDUCTED FOR EVENTS OCCURRING BETWEEN (B)(6) 2016 TO (B)(6) 2019 FOR ITEM EP-122848. - NO OTHER COMPLAINTS WERE IDENTIFIED FOR THIS ITEM NUMBER OTHER THAN (B)(4). - THEREFORE, THE CALCULATED OCCURRENCE RATE IS (B)(4). - HOWEVER, THE OCCURRENCE IN THIS CASE IS CALCULATED USING A SINGLE COMPLAINT. THEREFORE, THE CURRENT OCCURRENCE RATING IN THE RISK MANAGEMENT FILE ARE STILL RELEVANT AND HAVE NOT BEEN EXCEEDED; 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. CORRECTIVE ACTION TAKEN: NO CORRECTIVE ACTION REQUIRED AT THIS TIME. PREVENTIVE ACTION TAKEN: NO PREVENTIVE ACTION REQUIRED AT THIS TIME IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : PRODUCT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY ON (B)(6) 2012. ON (B)(6) 2019 THE (CEMENTED) EXCEED ABT E1 MULLER CUP WAS REVISED DUE TO LOOSENING. THE PATIENT IS PARTICIPATING IN A CLINICAL STUDY.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: MLRY-HD POR FMRL 11X160MM, CATALOG #: 11-104111, LOT #: 2465666. MEDICAL PRODUCT: 28MM M2A MOD HEAD -6MM NK, CATALOG #: 11-163660, LOT #: 0000746524. (B)(6). OCCUPATION: CLINICAL OPS MANAGER. 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 THE PATIENT HAD INITIAL SURGERY ON (B)(6) 2012. ON (B)(6) 2019 THE (CEMENTED) EXCEED ABT E1 MULLER CUP WAS REVISED DUE TO LOOSENING. THE PATIENT IS PARTICIPATING IN A CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529637 EXCEED ABT E1 MULLER CUP 28X48 POLYETHYLENE ACETABULUM PROSTHESIS LPH BIOMET UK LTD. N/A 2217582

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R