MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 4, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-4015
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Burning Sensation (2146); Joint Laxity (4526); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6) 02-012-50-4011 - tru tib aug 1/2 size 4, 5mm; (b)(6) 02-012-60-1612 - tru stem ext 16mm x 120mm; (b)(6) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(6) 02-012-60-1812 - tru stem ext 18mm x 120mm; (b)(6) 02-010-06-0240 - tru cc femoral size 4 left.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 27 months after a left total knee replacement revision procedure, the patient underwent a second revision procedure to address prosthesis wear, pain, "burning sensation", inflammation, infections, instability, limited range of motion, and loss of mobility.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, medical device problem code, type of investigation, investigation findings, investigation conclusions.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, range of motion, or the infection.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, radiographs, and relevant clinical information were not provided.

• Brand Name: LOGIC CC TIB INSERT SIZE 4, 15MM
• 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 ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19385796
• Report Number: 1038671-2024-01441
• Device Sequence Number: 4035736
• Product Code: JWH
• UDI-Device Identifier: 10885862266132
• UDI-Public: 10885862266132
• 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: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2025
• Device Catalogue Number: 02-012-65-4015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown