BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    MDR report key: 17643996 · Received August 29, 2023

    Report

    Report Number
    1038671-2023-02084
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    October 9, 2019
    Report Date
    December 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862207074
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B. PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED. D10/D11: CONCOMITANT MEDICAL PRODUCTS: 5228099 130-32-52 - CROWN CUP INLAY NEUTRAL GR.2,32MM. 4817026 136-32-51 - CROWN CUP INLAY,LAT.+5 GR.1,32MM. 5772139 180-01-50 - CROWN CUP,CLUSTER-HOLE GR.50. 5560528 180-01-52 - CROWN CUP,CLUSTER-HOLE GR.52. 6034390 180-01-54 - CROWN CUP,CLUSTER-HOLE GR.54. H3. INVESTIGATION RESULTS - THE DEVICE NOVATION CROWN CUP LINE WITH SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT¿S PAIN CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THERE IS NO CLINICAL INFORMATION PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION- NEW INVESTIGATION REQUIRED DUE TO INFORMATION FOUND IN TRANSLATED DOCUMENT. CORRECTION- B3 USE IMPLANT DATE, B5 DUE TO TRANSLATION OF OUS INFORMATION, B7 RIGHT HIP, H6 MEDICAL DEVICE PROBLEM CODE & INVESTIGATION FINDINGS- TO BE REINVESTIGATED DUE TO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    H10. H6. THE MOST LIKELY CAUSE FOR THE PENDING REVISION REPORTED DUE TO EARLY PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS; A NUMBER OF VARIABLES INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL) COULD HAVE ALL CONTRIBUTED TO THE INCREASED TREND IN WEAR/OSTEOLYSIS RELATED COMPLAINTS. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS D6B, G1, G3, G6, H1, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) THE MOST LIKELY CAUSE FOR THE PENDING REVISION REPORTED DUE TO EARLY PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS SPECIFIED AS A NUMBER OF VARIABLES INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL) COULD HAVE ALL CONTRIBUTED TO THE INCREASED TREND IN WEAR/OSTEOLYSIS RELATED COMPLAINTS. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B2 H6. BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED IN INCIDENT MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR/OSTEOLYSIS: COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS SUCH AS USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL). ADDITIONALLY, A CONTRIBUTING FACTOR MAY HAVE BEEN USING ANOTHER MANUFACTURER¿S FEMORAL COMPONENTS, WHICH IS CONSIDERED OFF-LABEL USE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION OUS, THAT THIS PATIENT HAD A LEFT HIP REVISED IN (B)(6) OF 2019. IT IS STATED THAT THE PATIENT HAS A NEED FOR AN IMMEDIATE REVISION, "PROBABLY" FOR (B)(6) 2025, AND HAS REPORTED PAIN AND PSYCHOLOGICAL IMPAIRMENTS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    CORRECTION-PATIENT HAD AN INITIAL LEFT HIP ARTHROPLASTY FOR ADVANCED ARTHROSIS WITH GAIT DISTURBANCE AND PROGRESSIVE HIP PAIN ON (B)(6) 2019. THE PATIENT UNDERWENT INPATIENT REHABILITATION SERVICES FOR AN UNSPECIFIED LENGTH OF TIME. ¿SUBSEQUENT EXAMINATIONS CONFIRMED THE SUSPICION THAT THE IMPLANT FROM YOUR HOUSE HAD CONSIDERABLE WEAR, WHICH IS WHY THE ATTENDING PHYSICIANS DETERMINED THAT THERE WAS AN IMMEDIATE NEED FOR REVISION.¿ REVISION SURGERY FOR THE LEFT HIP IS REPORTED TO BE SCHEDULED FOR (B)(6) 2025. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000485 NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS SEE H10 LZO EXACTECH, INC. 10885862207074

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R