MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return expected due to this being a legal case.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification, that a patient who had underwent a partial knee revision on (b)(6) 2018 in which an optetrak logic psc tibial insert was implanted, underwent a second revision surgery on (b)(6) 2022, approximately 3 years 5 months post the 2018 revision.Upon information and belief, plaintiff required revision surgery for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability and/or component loosening.
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, insufficient information.
Event or Problem Description
This report is for the second revision reported.The first revision indicated was reported under 1038671-2022-00915.
Additional Manufacturer Narrative
H6.Investigation results - the revision reported was likely the result of femoral loosening and polyethylene wear as stated in the operative notes.The femoral loosening was likely the result of an insufficient bond between the femoral component and the bone and/or patient-related conditions.The extent and root cause of the polyethylene wear cannot be determined as the devices were not available for evaluation and images of the explanted devices were not provided.These devices are used for treatments, not diagnosis.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, e1, e2, e3, h6 - health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings and h11.The reported event was unable to be confirmed due to limited information received from the customer.A definitive root cause was unable to be determined; however, may be the result of prosthesis wear, instability, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of users 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, 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: michael crader ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15220898
• Report Number: 1038671-2022-00916
• Device Sequence Number: 6720960
• Product Code: JWH
• UDI-Device Identifier: 10885862173492
• UDI-Public: 10885862173492
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/20/2026

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: 02/23/2024
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM
• Device Catalogue Number: 02-012-44-2013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 09/27/2022; 02/23/2024; 04/17/2026
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 10/24/2022; 03/28/2024; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female