MAUDE Adverse Event Report: EXACTECH, INC. INTEGRIP CC, CLUSTER 56MM,G3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	186-01-56
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 170-40-03, (b)(6)- biolox delta femoral head 40mm 0d, +3.5mm 180-65-30, (b)(6)- alteon 6.5mm screw, 30mm 180-65-40, (b)(6) - alteon 6.5mm screw, 40mm 101-05-30, (b)(6) - 3.2mm drill bit30mm 1pk 190-20-08, (b)(6) - alt ha s noclr std sz 8 multiple mdr reports were filed for this event, please see associated reports: 1038671-2022-01173.The most likely underlying cause for the revision reported is prosthesis wear and fracture 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).Both failure modes were confirmed from the reported radiographs and images provided.In addition, although metallosis was observed on the femoral head, the allegations of wear of the acetabular cup could not be confirmed from the provided images, and the device was 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
It was reported that approximately 59 months after a right total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear and osteolysis.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.

• Brand Name: INTEGRIP CC, CLUSTER 56MM,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: 21558493
• Report Number: 1038671-2025-01506
• Device Sequence Number: 19926999
• Product Code: JDI
• UDI-Device Identifier: 10885862038791
• UDI-Public: 10885862038791
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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 Catalogue Number: 186-01-56
• 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: 09/06/2022
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male