MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-2513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 67 months after a left total knee replacement procedure, the patient has experienced prosthesis wear, pain and discomfort, limited activities of daily living, impacted quality of life; debilitating injuries and damages, including but not limited to, pain and discomfort; swelling; gait impairment; poor balance; component part loosening; soft tissue damage; bone loss; bone damage; and other injuries presently undiagnosed, which all require ongoing medical care; future damages, including but not limited to cost of medical care; rehabilitation; home health care; loss of earning capacity; mental and emotional distress; and pain and suffering.No further issues or complications were reported.No additional information is available.Cases, (b)(4) is associated with this case.
Additional Manufacturer Narrative
D10 concomitant devices: 4862425 02-012-66-1000 - metaphyseal tibial cone, ml29mm 5130714 02-012-64-1212 - tru fluted stm ext 12mm x120mm blast 5160244 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t 5394431 204-70-00 - tibial stem ext.Screw.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or 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 2.5, 13MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19483263
• Report Number: 1038671-2024-01804
• Device Sequence Number: 8110213
• Product Code: JWH
• UDI-Device Identifier: 10885862173539
• UDI-Public: 10885862173539
• 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: 2018
• 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): 03/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2021
• Device Catalogue Number: 02-012-44-2513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Female