MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 2, 18MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, (b)(6) years old male patient returned with knee pain and instability.Sales rep.Was alerted by surgeon¿s office that he wanted to perform a femoral revision on an optetrak cck.Due to the fact that there was an offset tibia in the patient and it was decided to used the old cck.The femoral component was removed.The femur was recut and 20mm distal augments were used (up from 15mm).Stem length was increased from 120mm to 160mm and an appropriate cck insert, and offset screw were used.Patient was last known to be in stable condition following the event.The device is not available for evaluation.
Additional Manufacturer Narrative
Concomitant medical products: cc tibial insert sz 2, 18mm (cat# 208-22-18 / serial# (b)(4)); cc femoral sz 2 (cat# 208-01-02 / serial# (b)(4)); logic stem ext 14mm x 160mm (cat# 02-012-60-1416 / serial# (b)(4)); three peg patella 35mm (cat# 200-02-35 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.As reported, 59 years old male patient returned with knee pain and instability.Sales rep.Was alerted by surgeon¿s office that he wanted to perform a femoral revision on an optetrak cck.Due to the fact that there was an offset tibia in the patient it was decided that we must use the old cck.The femoral component was removed.The femur was recut and 20mm distal augments were used (up from 15mm).Stem length was increased from 120mm to 160mm and an appropriate cck insert, and offset screw were used.Patient was last known to be in stable condition following the event.The device is not available for evaluation.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.

• Brand Name: CC TIBIAL INSERT SZ 2, 18MM
• 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: 13061569
• Report Number: 1038671-2021-00731
• Device Sequence Number: 3912796
• Product Code: JWH
• UDI-Device Identifier: 10885862054203
• UDI-Public: 10885862054203
• 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
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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, 18MM
• Device Catalogue Number: 208-22-18
• 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: 12/02/2021
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 05/27/2022
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 74 KG