MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT CR POR FEM CR POR RIGHT SZ 3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient id: (b)(6).It was reported that a female patient, initial right knee implanted on (b)(6) 2021, presented to the clinic with pain and instability.The mechanical cuts appeared good on x-ray but the patients mcl appeared to be not functioning with notable gapping medially.A revision was performed on (b)(6) 2022, approximately 9 months post the initial implant procedure.Lateral releases and thicker poly did not solve the mid flexion instability, so the previous porous femur was converted to a stemmed cc femur with a cc insert.During the procedure, a slight crack of the medial condyle was noted during impaction of the femur, which occurred during impaction and adjusting rotation.The new implants were stable with good rom and the instability was significantly better per the surgeon.The explants are not available for return.Product not returning - explants not available.
Additional Manufacturer Narrative
No device return anticipated as they are not available for return.Concomitants: z062345, 02-022-51-3009 - truliant tib imp crc insert sz 3, 9mm, 7083097, 02-022-55-3030 - truliant por tib tray size 3f/3t, 6948376, 201-78-15 - holding pin mini sharp point 4 pk, 6947680, 201-78-98 - 2 pk, schanz pin, 4mm x 130mm, s316204, 521-78-23 - threaded pin size 2.3 collared 2pk, s300583, 521-78-32 - threaded pin size 3.0 collarless 2pk, s317555, 21-78-32 - threaded pin size 3.0 collarless 2pk, 3008421308, a10012 - gps implant kit v2.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.The crack of the medial condyle was noted during impaction and rotation of the femur, this was most likely due to the procedure.
Event or Problem Description
The crack happened during impaction and adjusting rotation.No other information is available to the representative.

• Brand Name: TRULIANT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15502468
• Report Number: 1038671-2022-01193
• Device Sequence Number: 5256399
• Product Code: JWH
• UDI-Device Identifier: 10885862315113
• UDI-Public: 10885862315113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: TRULIANT CR POR FEM CR POR RIGHT SZ 3
• Device Catalogue Number: 02-020-14-0330
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female