BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM

    MDR report key: 20358640 · Received October 3, 2024

    Report

    Report Number
    1038671-2024-03800
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    July 22, 2024
    Report Date
    February 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862153647
    PMA / PMN Number
    K103012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THE PATIENT MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND/OR OSTEOLYSIS: IMPLANTED WITH A LATERALIZED LINER, 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 CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR AND OSTEOLYSIS MAY HAVE BEEN 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 AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED COMPONENT AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    01-OCT-2024 ADDITIONAL INFORMATION" LEGAL CASE ¿ USA (MDL NO. 3044) PATIENT ID: (B)(6) + RIGHT HIP CASE-(B)(4) HIP (UNKNOWN SIDE) IS ASSOCIATED WITH THIS CASE. IT IS REPORTED VIA LEGAL DOCUMENTATION THE PLAINTIFF UNDERWENT RIGHT HIP REPLACEMENT (B)(6) 2015 AND UNDERWENT REVISION RIGHT HIP (B)(6) 2024 (SHORT FORM COMPLAINT ATTACHED). THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1732-2022 130-32-51 - NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS SERIAL: (B)(6) 510K: K121392 UDI: (B)(4) PRODUCT CODE: JDI, LPH, LWJ, LZO, MEH X-RAY: NO OPERATIVE NOTES: NO CONCOMITANT DEVICES: (B)(6) 180-01-48 - NV CROWN CUP CLSTR HOLE 48MM GROUP 1 (B)(6) 170-32-00 - BIOLOX DELTA FEMORAL HEAD 32MM OD, +0MM (B)(6) 164-12-09 - NOVATION ELEMENT RO X/O SZ 9 (B)(6) 120-65-25 - BONE SCREW 6.5MM DIA X 25MM LONG (B)(6) 101-05-30 - 3.2MM DRILL BIT30MM 1PK ORIGINAL SUMMARY LEGAL CASE ¿ USA LETTER OF PRESERVATION PATIENT ID: (B)(6) + HIP CASE-(B)(4) IS ASSOCIATED WITH THIS CASE VERY IMPORTANT¿REQUEST FOR PRESERVATION OF PATHOLOGY MATERIALS AND/OR MEDICAL DEVICES FROM UPCOMING PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091812 BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862153647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.