MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 2.5,10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT TIB IMP CRC INSERT SZ 2.5,10MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately three years post tka, patient presented to clinic with pain.A magnetic resonance imaging (mri) showed synovitis and a revision was performed.Surgeons commented that the femur and tibia were both well aligned and not mechanically loose.The patella had some ossifications that they removed.Surgeons also noted synovitis tissue and removed it.They saw some posterior wear on the insert with some damage to the posterior leading edge with suspected damage upon original insertion.A new insert was placed of same thickness (10 crc).Patient was last know to be in stable condition.The insert is not available for return.No further information available.X-rays and photos received.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3, h6 and h9 have been updated accordingly.(h3) the revision reported may have been the result of the reported pain and synovitis.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.However, this cannot be confirmed as the device was not returned for evaluation.The most probable root cause associated with the reported event of "prosthesis wear¿ is associated with undesirable or unexpected pain due to the presence of an implanted device, not caused by a post traumatic event (fall, car accident, etc.).

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 2.5,10MM
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14459919
• Report Number: 1038671-2022-00592
• Device Sequence Number: 4570340
• Product Code: JWH
• UDI-Device Identifier: 10885862312556
• UDI-Public: 10885862312556
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 2.5,10MM
• Device Catalogue Number: 02-022-51-2510
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown