MAUDE Adverse Event Report: EXACTECH, INC. INTEGRIP CC, CLUSTER 62MM, G4; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	INTEGRIP CC, CLUSTER 62MM, G4
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case - usa.It was reported that approximately 20 months after a total right hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, synovitis, and osteolysis.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitants (b)(6); 136-36-54 - nv gxl lnr, +5lat, 36mm g4-60/62mm cups.(b)(6); 101-05-20 - 3.2mm drill bit 20mm 1pk.(b)(6); 164-03-13 - element-stem, collared w/ha, std offset, sz 13.(b)(6); 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6); 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6); 170-36-00 - biolox delta femoral head 36mm od, +0mm.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.

• Brand Name: INTEGRIP CC, CLUSTER 62MM, G4
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: 20751339
• Report Number: 1038671-2024-04473
• Device Sequence Number: 12741157
• Product Code: KWZ
• UDI-Device Identifier: 10885862038821
• UDI-Public: 10885862038821
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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: 08/23/2023
• Device Model Number: INTEGRIP CC, CLUSTER 62MM, G4
• Device Catalogue Number: 186-01-62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/21/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male