MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	CR TIBIAL INSERT SZ4, 11MM
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a 62 y/o male patient had a left knee replacement (b)(6) 2009.Approximately 12 years and 2 months after the initial procedure the patient had a left knee revision on 28 feb 2022 due to a failed total knee arthroplasty.Revision op report rec'd on 23 apr 2023: poly was worn within the patella.There was moderate pitting but considered normal.No total destruction noted.No evidence of loosening.Noted to be a large cyst behind the femur.Sterile dressing was applied.The patient was awakened and taken to recovery room in good condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D10: concomitants: 1503366, 200-02-35 - three peg patella 35mm.1569246, 204-04-44 - trapezoid tibial tray sz 4f/4t.1155616, 232-02-04 - optetrak asy, cr porous femoral, sz 4, left.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04897.The following sections were updated: g1, h6.The following sections were corrected: b1, b2, d6a, g1, h6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, loss of range of motion, and/or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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 SZ4, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16984737
• Report Number: 1038671-2023-01083
• Device Sequence Number: 17860372
• Product Code: JWH
• UDI-Device Identifier: 10885862040305
• UDI-Public: 10885862040305
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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: 10/14/2012
• Device Model Number: CR TIBIAL INSERT SZ4, 11MM
• Device Catalogue Number: 200-24-11
• 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: 04/23/2023
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2007
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male