BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX D MOD CER HD 32MM STD

    MDR report key: 10957608 · Received December 7, 2020

    Report

    Report Number
    3002806535-2020-00515
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    November 11, 2020
    Report Date
    January 29, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. RADIOGRAPHS: ONE PRE-DISLOCATION ANTERIOPOSTERIOR (AP) RADIOGRAPH TAKEN ON (B)(6) 2020 (BASED ON INFORMATION ON THE RADIOGRAPH IMAGE) WAS PROVIDED WITH (B)(4) FOR ANALYSIS. THE G7 ACETABULAR SYSTEM COMPONENTS AND FEMORAL STEM APPEAR ADEQUATELY SIZED AND POSITIONED IN THE PRE-DISLOCATION AP RADIOGRAPH. THE CUP INCLINATION ANGLE WAS MEASURED TO BE 44.2 DEGREES FROM THIS RADIOGRAPH. THE PREFERRED ACETABULAR ORIENTATION IS 40 DEGREES INCLINATION AND 20 DEGREES ANTEVERSION AS PER THE SURGICAL TECHNIQUES FOR G7 ACETABULAR SYSTEM, BUT FINAL ACETABULAR POSITION DEPENDS ON PATIENT ANATOMY AND MAY VARY SLIGHTLY WITH APPROACH. THE MANUFACTURING HISTORY RECORDS FOR THE HIGH WALL G7 ARCOMXL LINER, ECHO BI-METRIC STEM, G7 ACETABULAR SHELL, DELTA MODULAR CERAMIC HEAD HAVE BEEN CHECKED AND VERIFY THAT THESE COMPONENTS WERE MANUFACTURED AND STERILIZED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED IN THE ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (PER) PROVIDED WITH THE LINKED COMPLAINT ((B)(4)), THE PATIENT IS A 65 YEARS OLD FEMALE WITH NO CONTRIBUTING CONDITIONS RELATED TO THE IMPLANT FAILURE. THE ISSUE IS DESCRIBED IN THE PER AS RECURRENT DISLOCATION. THEREFORE, IT IS POSSIBLE THAT THE IMPLANTS HAD DISLOCATED BEFORE THE DATE OF THE RADIOGRAPH PROVIDED. THE MAVEN MD¿ REVIEWER CASE REPORT BY MEDICAL METRICS INC. PROVIDED WITH THE LINKED COMPLAINT (B)(4) STATES THAT LEFT HIP ARTHROPLASTY COMPONENTS ARE ANATOMICALLY ALIGNED. THERE IS NO FRACTURE, DISLOCATION OR OTHER ABNORMALITY. THE INSTRUCTIONS FOR USE THAT WERE SUPPLIED WITH THE G7 ACETABULAR SYSTEM POLYETHYLENE ACETABULAR LINERS PROVIDE THE FOLLOWING GUIDANCE: EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, EXCESSIVE WEIGHT, AND OBESITY HAVE BEEN IMPLICATED WITH PREMATURE FAILURE OF CERTAIN IMPLANTS BY LOOSENING, FRACTURE, DISLOCATION, SUBLUXATION AND/OR WEAR. POSSIBLE ADVERSE EFFECTS: DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. THE REASON(S) FOR DISLOCATION COULD NOT BE ESTABLISHED BASED ON THE PROVIDED RADIOGRAPH AND OTHER INFORMATION. A COMPLETE ASSESSMENT IS NOT POSSIBLE WITHOUT ADDITIONAL RADIOGRAPHS (IMMEDIATE POST-PRIMARY AND PRE-REVISION), SURGICAL NOTES OF BOTH PRIMARY AND REVISION SURGERY, AND PATIENT DETAILS SUCH AS HEIGHT, WEIGHT AND ACTIVITY LEVEL, ALL OF WHICH ARE NOT AVAILABLE DUE TO COUNTRY REGULATIONS AND PATIENT PRIVACY. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM 164186. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM AND LOT COMBINATION. 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 TABLES COULD NOT BE SELECTED FOR COMPARISON. RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED EVENT STATES HIP REVISION DUE TO DISLOCATION. IN THE RISK FILE, DISLOCATION 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. THERE IS NOTHING TO SUGGEST THE DISLOCATION IS RELATED TO ITEM 164186. THE OUTCOME OF THIS COMPLAINT (SURGICAL INTERVENTION) IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMF. OCCURRENCE RATE HAS NOT BEEN CALCULATED FOR ITEM BIOLOX D MOD CER HD 32MM STD (164186), AS THE ROOT CAUSE HAS NOT BEEN IDENTIFIED, THEREFORE THE WE ARE UNABLE TO SELECT THE APPROPRIATE LINE IN THE RISK FILE. 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 UNDERWENT AN INITIAL HIP PROCEDURE ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2020. DURING THE PROCEDURE THE CUP, LINER AND HEAD WERE CHANGED TO A NEW HEAD AND G7 . DUAL MOBILITY. ORIGINAL CUP WAS LEFT, LINER AND HEAD WERE REMOVED WITH RELATIVE EASE, SURGEON PLACED TRAIL HEAD AND DUAL MOBILITY TRIAL LINERS AND PERFORMED A TRIAL. NEW IMPLANTS OPENED AND IMPLANTED.

    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 (PRODUCT LOCATION IS UNKNOWN). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: G7 HI-WALL ARCOMXL LNR 32MM F, CATALOG #: 010000811, LOT #: 3273168. MEDICAL PRODUCT: ECHO POR FMRL NC 10X130MM, CATALOG #: 192010, LOT #: 786040. MEDICAL PRODUCT: G7 PPS LTD ACET SHELL 54F, CATALOG #: 010000664, LOT #: 3019577. PATIENT INFORMATION STATUS: NOT PERMITTED BY COUNTRY REGULATIONS. 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 AN INITIAL HIP PROCEDURE ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2020. DURING THE PROCEDURE THE CUP, LINER AND HEAD WERE CHANGED TO A NEW HEAD AND G7. DUAL MOBILITY. ORIGINAL CUP WAS LEFT, LINER AND HEAD WERE REMOVED WITH RELATIVE EASE, SURGEON PLACED TRAIL HEAD AND DUAL MOBILITY TRIAL LINERS AND PERFORMED A TRIAL. NEW IMPLANTS OPENED AND IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428565 BIOLOX D MOD CER HD 32MM STD CERAMIC FEMORAL HEAD PROSTHESIS LZO BIOMET UK LTD. N/A 3015907

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R