MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: serial #: (b)(4), category #: cs-05cc - intersep calcium sulfate, serial #: (b)(4), category #: 02-012-42-5008 - logic pts, size 5, 8mm,.
Event or Problem Description
Legal case - (b)(4).Related case: (b)(4).As reported via legal documentation, this patient is verified left knee on (b)(6) 2016 and left knee revision (b)(6) 2021.She had left knee second revision (b)(6) 2022, approximately 1 year and 4 months after their 1st revision.Poly exchange.Postoperative diagnosis: failed left total knee replacement secondary to instability and polyethylene wear.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Serial #: (b)(4), category #: 02-012-44-5011 - logic tibia implant psc insert, sz 5, 11mm, serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k110547.Concomitants: serial #: (b)(4), category #: cs-05cc - intersep calcium sulfate, serial #: (b)(4), category #: 02-012-42-5008 - logic pts, size 5, 8mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (component code, type of investigation, investigation findings, investigation conclusions).The following sections were corrected: h6 (health effect - clinical code, medical device problem code).The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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 5, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523782617
• MDR Report Key: 16735094
• Report Number: 1038671-2023-00676
• Device Sequence Number: 15164440
• Product Code: JWH
• UDI-Device Identifier: 10885862173720
• UDI-Public: 10885862173720
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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?: No
• Device Expiration Date: 10/09/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM
• Device Catalogue Number: 02-012-44-5011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2014
• 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: Female