MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); Emotional Changes (1831); Discomfort (2330); Osteolysis (2377); Implant Pain (4561); Joint effusion (4849)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case - (b)(6).As reported via the legal department, on (b(6) 2014, the patient had a revision of a total knee replacement surgery on the right side was performed on the patient using exactech components.Over the course of time after this surgical procedure, the patient experienced pain and discomfort in her right knee, following up with their doctor on (b)(6) 2022.On (b)(6) 2022, the patient's doctor recommended a re-revision of the right knee replacement.The patient is scheduled to undergo a re-revision of the right knee replacement on (b)(6) 2023 approximately 8 years and 6 months after their first revision using exactech components.There is no indication that the initial implant used exactech devices.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.Unable to locate initial surgery in ebi.
Additional Manufacturer Narrative
Pending investigation.Code not available: pending revision.
Additional Manufacturer Narrative
H6: corrected the following: health effect clinical code, health effect impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.Manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided but may be related to inclusion of the polyethylene in the packaging recall.Potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: PS TIBIAL INSERTS SZ 3, 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; 3523771140
• MDR Report Key: 16702200
• Report Number: 1038671-2023-00615
• Device Sequence Number: 14908391
• Product Code: JWH
• UDI-Device Identifier: 10885862048332
• UDI-Public: 10885862048332
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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?: No
• Device Expiration Date: 01/05/2017
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 204-23-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 09/19/2024; 09/19/2024
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 09/23/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2009
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown