MAUDE Adverse Event Report: EXACTECH, INC. INTEGRIP CC, CLUSTER 48MM, G1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	INTEGRIP CC, CLUSTER 48MM, G1
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Fibrosis (3167); Implant Pain (4561)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.D10 concomitant devices: (b)(6), - nv gxl liner neutral, 32mm id group 1 cups; (b)(6), 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), 142-32-00 - cocr fem head 32mm +0 offset 12/14; (b)(6), 160-00-12 - pf stem tapered plasma sz 12.
Event or Problem Description
It was reported that approximately 115 months after a right total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, acetabular cup loosening, polyethylene induced synovitis, and proximal femoral osteolysis.Patient was also indicated for increasing pain in the right hip.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.The serial number (b)(6) is confirmed to be a part of recall number: z-1732-2022 x-ray: no.Operative notes: yes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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 115 months after a right total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, acetabular cup loosening, polyethylene induced synovitis, and proximal femoral osteolysis.Patient was also indicated for increasing pain in the right hip.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.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 48MM, G1
• 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: 21264119
• Report Number: 1038671-2025-00529
• Device Sequence Number: 21210183
• Product Code: JDI
• UDI-Device Identifier: 10885862038753
• UDI-Public: 10885862038753
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 03/13/2025

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: 12/17/2022
• Device Model Number: INTEGRIP CC, CLUSTER 48MM, G1
• Device Catalogue Number: 186-01-48
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/13/2025
• 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 Age: 80 YR
• Patient Sex: Female