MAUDE Adverse Event Report: EXACTECH, INC. LOGIC KNEE COMPONENTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ankylosis (4527)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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 that approximately 54 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, ankylosis.Revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The reason for the procedure documented is most likely due to loss of range of motion secondary to development of scar tissue/arthrofibrosis.The underlying reason for the loss of range of motion and/or development of scar tissue cannot be determined but may be related to patient conditions, previous surgical history, joint immobilization, or non-compliance with rehabilitation protocols.H6: corrected health effect, medical device, component, and investigation clinical codes.
Additional Manufacturer Narrative
Corrected d4/d5.The reason for the procedure reported is most likely due to loss of range of motion secondary to development of scar tissue/arthrofibrosis.The underlying reason for the loss of range of motion and/or development of scar tissue cannot be determined but may be related to patient conditions, previous surgical history, joint immobilization, or non-compliance with rehabilitation protocols.

• Brand Name: LOGIC KNEE COMPONENTS
• 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: 20622123
• Report Number: 1038671-2024-04270
• Device Sequence Number: 7452780
• Product Code: JWH
• UDI-Device Identifier: 10885862173485
• UDI-Public: 10885862173485
• 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: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2024

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: 12/09/2019
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 11/14/2024; 11/13/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 11/14/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female