MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC TIBIA PS MOD INSRT SZ 5 13MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 56 yo male patient, initially implanted on the right knee on (b)(6) 2015, was seen in the office for knee pain and instability.They were revised to a cc knee approximately 7 years 5 months post the initial implant procedure.The knee was revised to a large h32 femoral cone and a tibial con ml 39.The femur is revised to constrained condylar size 4 with a size 4 tibia.The femur had a 20 x 120 stem and tibia had a 16 x 80 stem with a size 4/19 mm constrained insert liner.The patient was last known to be in stable condition following the event.The devices are available for return.
Additional Manufacturer Narrative
Concomitant medical products: 02-010-01-0350 - logic femoral ps cem right sz 5, (b)(4); 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t, (b)(4); 200-02-38 - three peg patella 38mm, (b)(4); 204-34-02 - fluted stem extension 25l x 14 mm, (b)(4); 204-70-00 - tibial stem ext.Screw, (b)(4).Device return anticipated.Recall: z-2112 thru 2133-2021.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 subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.H7: z-0021-2022.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 5 13MM
• 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: 15348116
• Report Number: 1038671-2022-01017
• Device Sequence Number: 14683045
• Product Code: JWH
• UDI-Device Identifier: 10885862001948
• UDI-Public: 10885862001948
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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 Expiration Date: 08/26/2018
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 5 13MM
• Device Catalogue Number: 02-012-35-5013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2010
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male