MAUDE Adverse Event Report: EXACTECH, INC. LOGIC PSC TIB INS SZ 4 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-4017
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient was initially implanted with a right total knee arthroplasty (b)(6) 2017 and then approximately 5 years 6 months, later was surgically revision on (b)(6) 2023.Revision operative report of (b)(6) 2023, postoperative diagnosis: failed right total knee polyethylene and femoral component due to premature polyethylene wear and osteolysis due to poly recall.Patient revised to exactech devices.The patient was transferred to recovery in stable condition, there were no complications.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.There is no other information provided.
Additional Manufacturer Narrative
H10.D10.Concomitants: 4996482, 02-012-60-1612 - tru stem ext 16mm x 120mm 5107754, 02-020-11-0340 - truliant ps cem fem ps cem right sz 4 4896527, 02-022-45-4050 - truliant tib fit tray cem sz 4f / 5t 4954181, 200-02-38 - three peg patella 38mm 5022852, 204-70-00 - tibial stem ext.Screw pending investigation.There is no other information available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, a failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface, 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, component, and investigation clinical codes.

• Brand Name: LOGIC PSC TIB INS SZ 4 17MM
• 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 ; gainesville, FL 32653
• MDR Report Key: 18711061
• Report Number: 1038671-2024-00231
• Device Sequence Number: 7255933
• Product Code: JWH
• UDI-Device Identifier: 10885862248145
• UDI-Public: 10885862248145
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: 01/02/2022
• Device Catalogue Number: 02-012-44-4017
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 12/16/2024
• Date Device Manufactured: 01/08/2014
• 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: 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male