MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a male patient had a left knee replacement on (b)(6) 2015.Approximately 7 years and 4 months after the initial procedure the patient had a left knee revision on (b)(6) 2022 due to pain and instability of the knee.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.Revision op report on (b)(6) 2022: preoperatively, that patient's physical exam suggested moderate-sized effusion, but significant anterior draw sign greater than 10 mm without endpoint with the knee flexed 90 degrees.Postop diagnosis: failed left total knee replacement secondary to flexion gap instability.There was a moderate synovial reaction in the suprapatellar pouch and synovectomy of the suprapatellar pouch and medial and lateral gutters was affected.Polyethylene insert was removed and inspected and did not suggest that it was polyethylene wear but sagittal instability.Posterior compartment of the knee was also debrided of extraneous foreign body reactive synovium.The patient was awakened and taken to the recovery room in stable condition.There were no complications.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H6.Investigation results - the logic tibia implant psc insert with serial number 3624376 is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s instability 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.Instability is a known complication following total joint replacement surgery and is multifactorial in nature.The tibial insert was manufactured approximately 10 months prior to implant.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
The reason for the revision reported in cannot be confirmed from the information provided but may be the result of prosthesis wear, instability and/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.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17296851
• Report Number: 1038671-2023-01598
• Device Sequence Number: 7009527
• Product Code: JWH
• UDI-Device Identifier: 10885862173577
• UDI-Public: 10885862173577
• 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: 2015
• 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
• Report Date (Section B): 10/24/2024

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: 06/06/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM
• Device Catalogue Number: 02-012-44-3013
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 11/23/2024
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 12/14/2023; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2014
• 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: A
• 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 Age: 69 YR
• Patient Sex: Male