MAUDE Adverse Event Report: EXACTECH, INC. INTEGRIP CC, CLUSTER 54MM, G2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	186-01-54
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report number: 1038671-2023-02173 d10 concomitants: 120-65-20 - bone screw 6.5mm dia x 20mm long (b)(6), 120-65-20 - bone screw 6.5mm dia x 20mm long (b)(6), 142-36-00 - cocr fem head 36mm +0 offset 12/14 (b)(6), 164-03-13 - element-stem, collared w/ha, std offset, sz 13 (b)(6), 186-01-54 - integrip cc, cluster 54mm, g2 (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-02173.The most likely underlying cause for the revision 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.
Event or Problem Description
As reported via legal documentation the patient had a right hip replacement on (b)(6) 2014 due to severe osteoarthritis.Approximately 8 years and 2 months after the initial procedure the patient had a right hip revision on (b)(6) 2022.Patient experienced osteolysis, synovitis, failure of implant and pain.Revision op report noted that the acetabular component was partially loose, positioned in 50 degrees of abduction and 5 to 10 degrees of anteversion, there was evidence of wear of the poly liner.There was bone loss in the acetabulum paprosky iia with osteolysis in the ilium and pubic bone.The patient was transferred to the recovery room in stable condition after reversal of anesthesia.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: INTEGRIP CC, CLUSTER 54MM, G2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21072609
• Report Number: 1038671-2025-00067
• Device Sequence Number: 16998554
• Product Code: JDI
• UDI-Device Identifier: 10885862038784
• UDI-Public: 10885862038784
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2024
• Device Catalogue Number: 186-01-54
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 01/03/2025
• Date Device Manufactured: 06/06/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male