BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANMORE ACET CUP ARCOM 28X50

    MDR report key: 9846689 · Received March 18, 2020

    Report

    Report Number
    3002806535-2020-00156
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    November 24, 2019
    Report Date
    May 7, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    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: MODULAR HEAD COMPONENT, CATALOG #: UNKNOWN, LOT #: J3766138. MEDICAL PRODUCT: TPRLC 133 T1 PPS SO 16X152MM, CATALOG #: UNKNOWN, LOT #: 00880304489691. MEDICAL PRODUCT: CEMENT PALACOS R+ GENTAMICINE POEDER 12.5MG/G, CATALOG #: UNKNOWN, LOT #: 3974758. 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 ANTEROPOSTERIOR (AP) RADIOGRAPHS WERE PROVIDED WITH (B)(4): THREE POST-PRIMARY RADIOGRAPHS TAKEN ON (B)(6) 2019, ONE RADIOGRAPH WAS TAKEN ON (B)(6) 2019 SHOWING THE REPORTED HEAD SUBLUXATION AND ONE RADIOGRAPH TAKEN ON THE SAME DAY AFTER REDUCTION OF THE JOINT. THE POST-PRIMARY RADIOGRAPHS SHOW THE FEMORAL HEAD SITTING WITHIN THE ACETABULAR SHELL. THESE RADIOGRAPHS DO NOT SHOW THE PATIENT FULL PELVIS AND THEREFORE DO NOT HAVE THE NECESSARY BONY LANDMARKS TO DETERMINE THE INCLINATION ANGLE OF THE ACETABULAR COMPONENT. THE FIRST AP RADIOGRAPH TAKEN ON (B)(6) 2019 CONFIRMS THE DISLOCATION OF THE FEMORAL HEAD. THE SECOND AP RADIOGRAPH TAKEN ON THE SAME DAY SHOWS REPOSITIONING OF THE FEMORAL HEAD. THE CUP INCLINATION ANGLE MEASURED ON THIS RADIOGRAPH IS FOUND TO BE 46.2. THE STANMORE SURGICAL TECHNIQUE RECOMMENDS THAT DURING REAMING OF THE ACETABULUM THE SHAFT OF THE REAMER MUST BE ORIENTATED AT 30-40 DEGREES OF ABDUCTION, WITH AN ELEMENT OF ANTEVERSION DEPENDING ON THE APPROACH USED. BOTH POST-PRIMARY AND POST-REDUCTION RADIOGRAPHS SHOW THAT DEBRIS MAY BE PRESENT LATERAL TO THE FEMORAL HEAD WITHIN THE JOINT SPACE, WHICH COULD BE EXTRUDED BONE CEMENT, A FRAGMENT OF BONE OR AN OSTEOPHYTE. THE ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER) PROVIDED WITH THE COMPLAINT STATES THAT PATIENT HAD A LUXATION ON (B)(6) 2019 AFTER TURNING LEG INWARDS WHEN PUTTING ON SOCKS. THE INFORMATION FOR USE (IFU) [2] LEAFLET THAT WAS PACKAGED WITH THE ACETABULAR CUP STATES THAT: WARNINGS AND PRECAUTIONS: IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. BIOMET JOINT REPLACEMENT PROSTHESES PROVIDE THE SURGEON WITH A MEANS OF REDUCING PAIN AND RESTORING FUNCTION FOR MANY PATIENTS. WHILE THESE DEVICES ARE GENERALLY SUCCESSFUL IN ATTAINING THESE GOALS, THEY CANNOT BE EXPECTED TO WITHSTAND THE SAME ACTIVITY LEVELS AND LOADS OF NORMAL HEALTHY BONE AND JOINT TISSUE. PATIENT WARNINGS: POSTOPERATIVE CARE IS IMPORTANT. THE PATIENT MUST BE WARNED OF THE LIMITATIONS OF THE RECONSTRUCTION AND THE NEED FOR PROTECTION OF THE IMPLANTS FROM FULL WEIGHT BEARING OR LOAD BEARING UNTIL ADEQUATE FIXATION AND HEALING HAS OCCURRED. THE PATIENT IS TO BE CAUTIONED TO GOVERN ACTIVITIES, PROTECTING THE JOINT REPLACEMENT FROM UNREASONABLE STRESS CONDITIONS. EXCESSIVE ACTIVITY, FAILURE TO CONTROL BODY WEIGHT AND TRAUMA AFFECTING THE JOINT REPLACEMENT HAVE BEEN ASSOCIATED WITH PREMATURE FAILURE OF THE RECONSTRUCTION BY LOOSENING, FRACTURE AND/OR WEAR OF THE IMPLANTS. POSSIBLE ADVERSE EFFECTS: -DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. THE MANUFACTURING HISTORY RECORDS (MHRS) FOR THE STANMORE CEMENTED ARCOM ACETABULAR CUP HAVE BEEN CHECKED AND VERIFY THAT THE CUP WAS MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. THE REASON FOR THE DISLOCATION CANNOT BE DETERMINED WITHOUT FURTHER RADIOGRAPHIC, SURGICAL AND PATIENT INFORMATION IN THIS INSTANCE. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 1 SIMILAR COMPLAINT FOUND FOR THE ITEM 165781. THERE WERE TRENDS IDENTIFIED FROM THE COMPLAINT HISTORY REVIEW; SAME LOT NUMBER FOUND IN THE SIMILAR COMPLAINT (B)(4). NO TRENDS COULD BE IDENTIFIED IN THE CAUSE. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: 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, LINES 23, 24 AND 25 DISLOCATION/SUBLUXATION RELATE TO THE REPORTED EVENT. THESE LINES HAVE A SEVERITY SCORE OF 4 DEFINED IN THE RMP AS RESULTS IN PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE / NECESSITATES SURGICAL INTERVENTION. THE COMPLAINT STATES MEDICAL INTERVENTION TOOK PLACE AT THE ER. THEREFORE, 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 CALENDAR YEARS PRIOR TO EVENT DATE, BEING NOV 2019. SALES (NOV 2016 TO NOV 2019) = (B)(4) UNITS. COMPLAINTS SEARCH WAS CONDUCTED FOR EVENTS OCCURRING BETWEEN NOV 2016 TO NOV 2019 FOR ITEM 165781. 2 COMPLAINTS WERE IDENTIFIED FOR THIS ITEM NUMBER INCLUDING (B)(4). THEREFORE, THE CALCULATED OCCURRENCE RATE IS (B)(4) IN (B)(4) OR (B)(4). THIS IS ABOVE THE ESTIMATED OCCURRENCE RATE AS PER THE RMF WHICH ESTIMATES AN ACCEPTABLE OCCURRENCE RATE OF 2 ((B)(4)). SINCE THE OCCURRENCE CALCULATION IS BASED ON ONLY 2 COMPLAINTS, 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 TWO INSTANCES 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 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 INVOLVED IN A CLINICAL STUDY UNDERWENT A PRIMARY THP ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT HAD A LUXATION ON (B)(6) 2019 AFTER TURNING LEG INWARDS WHEN PUTTING ON SOCKS. REPOSITIONING WAS DONE AT THE ER. SUBSEQUENTLY, A REPOSITION WAS PERFORMED DUE TO LUXATION. ON (B)(6) 2019 THERE WAS A SUBLUXATION WHILE SITTING IN A CHAIR, PATIENT DID NOT COME TO THE HOSPITAL. PATIENT IS NOT HAVING PAIN, FEELS INSECURE ABOUT THE HIP. NEEDS TO PERFORM EXERCISES. PATIENT STUDY NUMBER IS (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A PRIMARY HIP ATHROPLASTY. SUBSEQUENTLY, THE PATIENT SUFFERED A DISLOCATION WHEN PUTTING ON SOCKS. REPOSITIONING WAS DONE AT THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310826 STANMORE ACET CUP ARCOM 28X50 HIP PROTHESIS JDI BIOMET UK LTD. N/A 6122609

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R