MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 6524807 02-020-11-0350 - truliant ps cem fem ps cem right sz 5.6530757 02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t.6562081 200-02-38 - three peg patella 38mm.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2020.Approximately 1 year and 2 months after the initial procedure the patient had a right knee revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.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.Diagnosis: failed right total knee replacement secondary to arthrofibrosis findings: extensive scar tissue was found along the lateral gutter with very thickened scar involving the lateral collateral ligament, the it band, the lateral patellar retinaculum.The posterior capsule was extremely thickened and scarred with some areas of heterotopic calcification, very, very thickened posterior capsule scar.The medial collateral ligament was intact.There were significant adhesions between the medial skin flap and the quadriceps, and the quadriceps in the region of the mid vastus incision was also significantly scarred.After mobilizing the scar tissue, excising most of the scar tissue from the lateral gutter, freeing the patella, freeing the medial gutter and flap, and performing a medial release of the superficial medial collateral ligament.Polyethylene insert was removed.There were no complications during the procedure.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM
• 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: 17406769
• Report Number: 1038671-2023-01796
• Device Sequence Number: 15326877
• Product Code: JWH
• UDI-Device Identifier: 10885862173720
• UDI-Public: 10885862173720
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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 Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM
• Device Catalogue Number: 02-012-44-5011
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male