MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Inflammation (1932); Pain (1994); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	04/22/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that this patient was implanted with an optetrak logic device on (b)(6) 2016 with no reported revision.No other patient information/medical history reported.No images of the device are provided.There is no device information provided.No other information is available.
Additional Manufacturer Narrative
The reason for prosthesis wear cannot be confirmed from the information provided but may be the result of prosthesis wear and instability as reported or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear and instability cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation as the devices remain implanted and no images, radiographs, or relevant clinical information were provided.
Additional Manufacturer Narrative
D1: corrected.D4: corrected.D10: concomitant devices: 02-010-06-0340 - tru cc femoral size 4 right.02-010-06-0541 - tru post.Aug.Size 4, 5mm.02-010-06-0541 - tru post.Aug.Size 4, 5mm.02-012-42-4008 - logic pts, size 4, 8mm.02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.02-012-60-1480 - tru stem ext 14mm x 80mm.02-012-60-1812 - tru stem ext 18mm x 120mm.02-012-65-4011 - tru cc tib insert size 4, 11mm.200-02-38 - three peg patella 38mm.204-70-00 - tibial stem ext.Screw.208-06-04 - cc distal fem augment sz 4, 10mm.208-06-04 - cc distal fem augment sz 4, 10mm.

• Brand Name: LOGIC CC TIB INSERT SIZE 4, 11MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 18947836
• Report Number: 1038671-2024-00607
• Device Sequence Number: 20845988
• Product Code: JWH
• UDI-Device Identifier: 10885862266118
• UDI-Public: 10885862266118
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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: 09/23/2023
• Device Catalogue Number: 02-012-65-4011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 09/18/2024; 09/18/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 09/19/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown