MAUDE Adverse Event Report: EXACTECH, INC. INTEGRIP CC, CLUSTER 58MM, G3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	186-01-58
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately seven years post initial left tha, the 71 y/o male patient presented with complaints of pain and dissatisfaction with their primary exactech hip.The patient had a recall gxl poly liner and was booked for revision surgery.The patient underwent total acetabular revision to a exactech 28mm cocr +10mm head and competitor's devices.There was no breakage of device.There was a 30-45 mins surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-ray and images received.The devices are not available for evaluation due to the products were sent to the lab at the hospital.
Additional Manufacturer Narrative
Concomitant products: biolox delta femoral head 40mm 0d, +3.5mm (cat# 170-40-03 / serial# (b)(6), alteon 6.5mm screw, 35mm (cat# 180-65-35 / serial# (b)(6), integrip cc, cluster 58mm, g3 (cat# 186-01-58 / serial# (b)(6).The most likely underlying cause for the revision reported is prosthesis wear and 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).Additional reasons for the revision may be acetabular loosening.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.

• Brand Name: INTEGRIP CC, CLUSTER 58MM, G3
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22456864
• Report Number: 1038671-2025-02444
• Device Sequence Number: 8291473
• Product Code: JDI
• UDI-Device Identifier: 10885862038807
• UDI-Public: 10885862038807
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K102975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2025

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: 04/01/2024
• Device Catalogue Number: 186-01-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 07/09/2025
• Date Device Manufactured: 04/04/2014
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male