MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM; SEE H10

Catalog Number	02-012-35-2511
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via legal notification, that the patient underwent an initial left total knee replacement surgery in or around 2013.In the ensuing time, patient began to suffer from symptoms, including pain and lack of mobility.As a result of these symptoms, patient underwent a left knee revision surgery on (b)(6) 2022, approximately 9 years 10 months post initial procedure.Patient experiences, pain, lack of mobility, and enduring limitations on activities of daily living, quality of life and ability to perform work functions.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues; device information is not provided.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Further updates and or re-opened investigation results will be provided within 30 days of receipt.
Event or Problem Description
As reported via legal documentation, this patient had left knee replacement on (b)(6) 2013.They had left knee revision surgery on (b)(6) 2022, approximately 9 years 5 months after their primary procedure.(b)(6) 2022 op report post-op diagnosis: wear of articular bearing surface of internal prosthetic left knee joint.The left knee was noted to show moderate effusion with significant joint laxity.During surgery, the patient was noted to have significant effusion and synovitis.There was delamination of the polyethylene but no evidence of prosthesis loosening.The patella was removed because it was worn and loose.The patient tolerated the procedure well and was transferred to the recovery room in stable condition.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.
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, instability, and patellar 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 PS MOD INSRT SZ 2.5 11MM
• Common Device Name: SEE H10
• 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: 16529308
• Report Number: 1038671-2023-00416
• Device Sequence Number: 11418487
• Product Code: JWH
• UDI-Device Identifier: 10885862001771
• UDI-Public: 10885862001771
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2020
• Device Catalogue Number: 02-012-35-2511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 05/15/2023; 05/15/2023; 02/12/2025
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/17/2023; 07/06/2023; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown