MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an 82 yo male patient, who had bilateral knee replacements, initial left knee implanted on (b)(6) 2009, underwent a revision procedure on (b)(6) 2023, approximately 13 years 9 months post the initial procedure.The patient presented to the surgeon¿s office with complaints of pain, swelling, instability and dissatisfaction with their tka¿s.The left hurt more than the right at this time.The patient underwent a poly insert and patella implant swap.The patient had recalled poly implants.There were no device breakages or surgical delays reported.The patient was last known to be in stable condition following the event.Device images and x-rays were provided.No device return anticipated.The implant was sent to the lab and legal at the hospital.No further information known.Right knee reported under 1038671-2023-02062.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomittants: 200-01-03 - cemented cr femoral sz 3 8556009 200-04-34 - cemented finned tib.Tra sz 3f/4t 1544958 200-05-23 - inset patella 23mm 1537610 additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision may be the result of the patient¿s reported pain and swelling, caused by prosthesis wear and instability.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.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 3, 11MM, SLOPE ++
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17632977
• Report Number: 1038671-2023-02063
• Device Sequence Number: 18079720
• Product Code: JWH
• UDI-Device Identifier: 10885862041265
• UDI-Public: 10885862041265
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 04/06/2013
• Device Model Number: CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++
• Device Catalogue Number: 200-73-11
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2008
• 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
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 100 KG