MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561)
Date of Event	06/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2014.Approximately 2 years and 2 months after the initial procedure the patient had a right knee revision on (b)(6) 2016 due to pain, difficulty with walking and activities.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H3: investigation results - the revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear could not be determined as the device was not returned for evaluation, and image, radiographs, and product information were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d1/d2a/d2b, d4, g3, h4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, b, c, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CR TIBIAL INSERT SZ 2, 9MM
• 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: miguel sosa ; 3523771140
• MDR Report Key: 17009021
• Report Number: 1038671-2023-01150
• Device Sequence Number: 7549573
• Product Code: JWH
• UDI-Device Identifier: 10885862040190
• UDI-Public: 10885862040190
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted 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): 01/06/2025

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: 01/25/2018
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 200-22-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 02/08/2024; 01/03/2025
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 02/13/2024; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2010
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown