BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BISPHERICAL SHELL 48C

    MDR report key: 11670585 · Received April 15, 2021

    Report

    Report Number
    3002806535-2021-00120
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 24, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    UDI-DI
    05019279515677
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO CORRECT INFORMATION PREVIOUSLY PROVIDED IN THE NARRATIVE/DATA. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, H1, H2, H10. THE FOLLOWING LINE IN THE NARRATIVE/DATA WAS MADE IN ERROR: A DIMENSIONAL INSPECTION HAS BEEN CARRIED OUT AND 110003621 BIOLOX DELTA CER LNR 32MM D BATCH 6294411 WAS FOUND TO BE CONFORMING TO DRAWING SPECIFICATIONS, SEE ATTACHED INSPECTION FORM. THE INLAY/LINER IS A G7 NEUTRAL E1 LINER E1 POLY NOT A CERAMIC LINER. THE E1 POLY LINER WAS NOT RETURNED TO THE UK. THE LINER IS INVESTIGATED UNDER LINKED COMPLAINT, (B)(4) AND WILL BE REPORTED BY MEDWATCH FACILITY WARSAW BIOMET - (B)(4). THE UPDATED SUMMARY IS PROVIDED BELOW: PRODUCT HAS BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. A VISUAL INSPECTION THE G7 BISPHERICAL SHELL (110017330) SHOWS SIGNS OF SCRATCHES AROUND THE RECESS OF THE APICAL PLUG HOLE, MOST LIKELY CAUSED DURING REMOVAL. A DIMENSIONAL INSPECTION HAS BEEN CARRIED OUT AND G7 BISPHERICAL SHELL ITEM NO. 110017330 BATCH 6892575 WAS FOUND TO BE CONFORMING TO DRAWING SPECIFICATIONS. THE G7 BISPHERICAL SHELL WAS MEASURED, THE LINER WAS NOT RETURNED TO UK. THE LINER IS INVESTIGATED UNDER LINKED COMPLAINT, (B)(4). 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 REPORTED EVENTS FOR LINER SEATING ISSUES FOR THE SAME ITEM NUMBER 110017330. THE MOST LIKELY ROOT CAUSE FROM THE INVESTIGATION FINDINGS IS THAT THE E1 POLY LINER WAS IMPACTED WITH THE SCALLOPS INCORRECTLY ALIGNED OR THE SHELL HAS BECOME DEFORMED BY IMPACTION INTO THE ACETABULUM PREVENTING IT SEATING CORRECTLY. HOWEVER, THIS CANNOT BE CONFIRMED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. THE COMPLAINT STATES, TYPE OF SURGERY: HIP PROSTHESIS, PATIENT RISK YES, DUE TO PROLONGED SURGERY TIME NO FRAGMENTS IN THE SURGICAL WOUND. G7 CUP INLAY DID NOT JAM. THE CUP HAD TO BE CHANGED TO SIZE 50. SIZE 48 WAS ONLY CONSULTED ONCE, WHICH DR. (B)(6) ALSO COMPLAINED ABOUT, AS THIS POSED A RISK TO THE PATIENT. IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE (B)(6) 2021. SUBSEQUENTLY, (B)(6) 2021 THE LINER WOULD NOT SEAT IN THE CUP. THE CUP HAD TO BE CHANGED TO SIZE 50. SIZE 48 WAS ONLY CONSULTED ONCE, WHICH DR. (B)(6) ALSO COMPLAINED ABOUT, AS THIS POSED A RISK TO THE PATIENT. THERE WAS A 40-MINUTE DELAY IN THE PROCEDURE. A VISUAL INSPECTION THE G7 BISPHERICAL SHELL (110017330) SHOWS SIGNS OF SCRATCHES AROUND THE RECESS OF THE APICAL PLUG HOLE, MOST LIKELY CAUSED DURING REMOVAL. A DIMENSIONAL INSPECTION HAS BEEN CARRIED OUT AND 110003621 BIOLOX DELTA CER LNR 32MM D BATCH 6294411 WAS FOUND TO BE CONFORMING TO DRAWING SPECIFICATIONS, SEE ATTACHED INSPECTION FORM. THE MOST LIKELY ROOT CAUSE FROM THE INVESTIGATION FINDINGS IS THAT THE E1 POLY LINER WAS IMPACTED WITH THE SCALLOPS INCORRECTLY ALIGNED OR THE SHELL HAS BECOME DEFORMED BY IMPACTION INTO THE ACETABULUM PREVENTING IT SEATING CORRECTLY. HOWEVER, THIS CANNOT BE CONFIRMED WITH THE INFORMATION PROVIDED. A REVIEW OF THE COMPLAINTS DATABASE SHOWS THAT WE HAVE RECEIVED NO REPORTED EVENTS FOR LINER SEATING ISSUES FOR THE SAME ITEM NUMBER 110017330 PRIOR TO THE REPORTED EVENT. THE SEVERITY OF THE REPORTED EVENT AND CALCULATED OCCURRENCE FOR SIMILAR COMPLAINTS ARE IN LINE WITH THE RISK FILE THE OVERALL SCORE IS MEDIUM RISK. CAPA: NO CORRECTIVE OR 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 SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A PRIMARY HIP ARTHROPLASTY ON (B)(6) 2021. THE LINER WOULD NOT SEAT IN THE CUP. THE CUP SIZE HAD TO BE CHANGED. THERE WAS A 40 MINUTE DELAY IN THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE. DURING THE PROCEDURE, THE LINER WOULD NOT SEAT INTO THE CUP. THE SIZE 48 CUP WAS REMOVED AND REPLACED WITH A SIZE 50 CUP.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT: CONCOMITANT PRODUCTS: 010000847 6495751 G7 NEUTRAL E1 LINER 32MM C. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 UNDERWENT A HIP PROCEDURE. DURING THE PROCEDURE, THE LINER WOULD NOT SEAT INTO THE CUP. THE SIZE 48 CUP WAS REMOVED AND REPLACED WITH A SIZE 50 CUP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569421 G7 BISPHERICAL SHELL 48C HIP PROTHESIS JDI BIOMET UK LTD. N/A 6892575 05019279515677

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE