BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRIP CC, CLUSTER 54MM, G2

    MDR report key: 20290514 · Received September 24, 2024

    Report

    Report Number
    1038671-2024-03669
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    August 15, 2023
    Report Date
    August 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862038784
    PMA / PMN Number
    K102975
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, G4.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM 5211619; 180-65-20 - ALTEON 6.5MM SCREW, 20MM 4946663; 180-65-25 - ALTEON 6.5MM SCREW, 25MM 5365980; 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2 5371861; 188-00-08 - WEDGE PLASMA S/O SZ 8 5028350; 188-00-09 - WEDGE PLASMA S/O SZ 9 5279048. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-1732-2022; 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS SUBMITTED IN ERROR . NO INFORMATION WAS RECEIVED TO INDICATE THE NEED FOR AN ADDITIONAL COMPLAINT RECORD THAT WOULD NECESSITATE REGULATORY REPORTING; THEREFORE, THIS COMPLAINT WILL BE INVALIDATED.

    Description of Event or Problem · 0

    HIP WAS DISLOCATED POSTERIOR. STEM WAS STABLE AND WELL FIXED. ABDUCTORS WERE MINIMAL DAMAGE, 20% DAMAGE FROM OSTEOLYSIS. SIGNIFICANT AMOUNT OF DENSE SCAR TISSUE WAS RESECTED FROM THE AROUND THE HIP JOINT. POLY LINER FROM CUP USING DRILL SCREW TECHNIQUE. CUP OUT USED TO REMOVE THE CUP. IT WAS ELECTED TO PLACE A DUAL MOBILITY LINER. THE LINER WAS INSERTED INTO THE CUP AND IMPACTED. IT IS NOTED TO BE WELL SEATED AND LOCKED INTO POSITION. REAL HEAD IMPACTED ONTO THE STEM. HIP WAS REDUCED INTO THE CONSTRAINED CUP. IT WAS VERY STABLE AND DID NOT DISLOCATE OR IMPINGE WITH HIP FLEXION 90 DEGREES AND INTERNAL ROTATION TO 90 DEGREES. PATIENT WAS REVERSED FROM ANESTHESIA AND MOVED ONTO THE HOSPITAL BED WITHOUT DIFFICULTY. PATIENT WAS TAKEN TO PACU IN STABLE CONDITION. CUP WAS REMOVED WITHOUT DIFFICULTY - MINIMAL BONE IN GROWTH. STEM WAS STABLE, WELL FIXED, AND WELL POSITIONED - THEREFORE KEPT THE STEM. VERY STABLE RECONSTRUCTION. MODERATE AMOUNT OF SOFT TISSUE CONSISTENT WITH OSTEOLYSIS. MODERATE AMOUNT OF ACETABULAR BONE DAMAGE DUE TO OSTEOLYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 64 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, OSTEOLYSIS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290106 INTEGRIP CC, CLUSTER 54MM, G2 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862038784

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| H SEE H11.