MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: serial #: (b)(4), category #: 02-010-01-0330 - logic femoral ps cem right sz 3; serial #: (b)(4), category #: 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t; serial #: (b)(4), category #: 200-02-32 - three peg patella 32mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Legal case - (b)(6).Per information received by the legal department, the patient had an initial right knee replacement on (b)(6) 2015.Approximately 6 years and 9 months after first replace the patient had a revision on (b)(6) 2022.Severe poly wear along the medial and lateral surface with a broken portion of the ps post tip as well.Grossly loose femoral and tibial implants - removed easily with minimal bone loss.Massive distal femoral medial and lateral condyle bone loss - medial condyle was so damaged there was a fracture present that required two screw fixation.Revised to zimmer.Patient sent to pacu in stable condition.Serial #:(b)(4), category #: 02-012-44-3009 - logic tibia implant psc insert, sz 3, 9mm, serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.Recall: z-0021-2022.510k: k110547.Concomitants: serial #: (b)(4), category #: 02-010-01-0330 - logic femoral ps cem right sz 3; serial #: (b)(4), category #: 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t; serial #: (b)(4), category #: 200-02-32 - three peg patella 32mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, fracture, tibial loosening, and femoral loosening.Or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16708191
• Report Number: 1038671-2023-00633
• Device Sequence Number: 14395618
• Product Code: JWH
• UDI-Device Identifier: 10885862173553
• UDI-Public: 10885862173553
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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 Expiration Date: 06/23/2020
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
• Device Catalogue Number: 02-012-44-3009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female