MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	01/11/2023
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.
Event or Problem Description
Legal case - usa (b)(4).It was reported that approximately 8 months after a right total knee replacement procedure, the patient has experienced prosthesis wear, suffered from pain, swelling, and decreased range of motion.The implantation of the exactech device and subsequent revisions have caused personal injuries, severe pain and suffering, mental anguish, emotional distress, fear, loss of enjoyment of life, medical expenses, and financial losses, and he will sustain future damages including but not limited to cost of medical care, rehabilitation, mental and emotional distress, and pain and suffering.Accordingly, plaintiff is seeking compensatory and special damages, including attorneys' fees and costs, and all other available remedies under the law.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and loss of range of motion.However, the reported prosthesis wear and loss of range of motion could not be confirmed and potential contributions of 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.H6: corrected medical device clinical codes.
Additional Manufacturer Narrative
D4 corrected.D10 concomitant devices (b)(6) , 02-012-50-3011 - tru tib aug 1/2 size 3, 5mm.(b)(6) , 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t.(b)(6) 201-78-15 - holding pin mini sharp point 4 pk.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 4, 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville 32606 6841
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 19987410
• Report Number: 1038671-2024-02848
• Device Sequence Number: 17883501
• Product Code: JWH
• UDI-Device Identifier: 10885862307781
• UDI-Public: 10885862307781
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2024

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 Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 02-022-51-4015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 11/02/2024; 10/02/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/04/2024; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• 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: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown