BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS

    MDR report key: 17388069 · Received July 25, 2023

    Report

    Report Number
    1038671-2023-01755
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    June 21, 2023
    Report Date
    August 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207043
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AS SPECIFIED IN THE HHE: COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED AND IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION DUE TO EARLY PROSTHESIS WEAR REPORTED IS A COMBINATION OF RISK FACTORS SPECIFIED IN THE HHE. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCT: 101-05-30 - 3.2MM DRILL BIT30MM 1PK. 5446327. 170-40-93 - BIOLOX DELTA FEMORAL HEAD 40MM OD, -3.5MM. 4846925. 180-65-40 - ALTEON 6.5MM SCREW, 40MM. 5431263. 186-01-58 - INTEGRIP CC, CLUSTER 58MM, G3. 5350107. 190-21-08 - ALT HA S NOCLR EXT SZ 8. 4964079.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: C, D, E, G. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION DUE TO EARLY PROSTHESIS WEAR REPORTED IS A COMBINATION OF 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). HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. 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

    AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL RIGHT THA, THIS 72 Y/O MALE PATIENT WAS REVISED. THE PATIENT RETURNED TO SURGEONS OFFICE COMPLAINING ABOUT THEIR PRIMARY HIP. PAIN AND DISSATISFACTION. UPON EXAMINATION AND IMAGING THE POLY SHOWED WEAR AND IS INVOLVED IN THE RECALL. THE PATIENT UNDERWENT REVISION RIGHT THA ON (B)(6) 2023 WHERE THE HEAD AND POLY LINER WERE SWAPPED. A NEW VITAMIN E LINER AND CERAMIC HEAD WERE IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNKNOWN MEDICAL HISTORY. NO X-RAYS PROVIDED. PRODUCT NOT BEING RETURNED - THE IMPLANTS WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426305 NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK UNK 10885862207043

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male SEE H10