MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-4013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Pending investigation.There is no other information provided.
Event or Problem Description
It was reported via legal documentation that a patient had a left knee arthroplasty on (b)(6) 2018, with no revision surgery reported.There was no other patient/medical information provided.No x-rays or images were provided.There is no other information available.
Additional Manufacturer Narrative
Updated device information based on new information received.
Additional Manufacturer Narrative
D4: corrected.G4: corrected.The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or 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 TIBIA IMPLANT PSC INSERT, SZ 4, 13MM
• 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: 19282513
• Report Number: 1038671-2024-01175
• Device Sequence Number: 18054593
• Product Code: JWH
• UDI-Device Identifier: 10885862173652
• UDI-Public: 10885862173652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 10/28/2024

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: 06/16/2024
• Device Catalogue Number: 02-012-44-4013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: Not provided; 11/24/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 09/05/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown