MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 22MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 2, 22MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2021
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, a poly swap was scheduled for (b)(6) 2021.All needed materials (implants and instruments) were prepared the day before.The implant record was obtained.The surgeon was told his only options were replacing the 22mm insert that was in there or increasing to a 26mm or 30mm.Early in the day on the date of surgery we (rep and surgeon's staff) looked at the pics of the case and informed the surgeons of our concerns.The femur needed to be revised and due to the sizes of existing implants our systems parameters may no cover the gap and a total femur may be needed.The surgeon canceled the procedure on the left knee and proceeded to scope the right knee.Patient was scheduled for a poly swap.That was deemed inadequate in a group discussion.The procedure was canceled and referred to a revision specialist.Patient continued on with scope of right knee but left knee revision was cancelled and referred to another hss surgeon.The were no devices removed to be returned for analysis.Additional information received indicates that left knee revision was scheduled due to massive instability and pain.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing 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.

• Brand Name: CC TIBIAL INSERT SZ 2, 22MM
• 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: 12856389
• Report Number: 1038671-2021-00626
• Device Sequence Number: 4828989
• Product Code: JWH
• UDI-Device Identifier: 10885862054210
• UDI-Public: 10885862054210
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (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): 07/05/2022

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: CC TIBIAL INSERT SZ 2, 22MM
• Device Catalogue Number: 208-22-22
• 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: 11/04/2021
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Male