MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 1, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-21-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #3 of 3 for this event.As reported by legal documentation, a patient underwent a left total knee arthroplasty.Subsequently, approximately ten (10) years later, the patient presented to surgeon complaining of pain unrelated to injury/work injury.Patient reports 8 out of 10 on pain scale in left and right knees.Ongoing intermittent aching.Gradually worsening.Aggravated by: bending, stretching, straightening, exercise, kneeling, squatting, standing, walking, stairs.Patient reported falling on both knees while walking the dog.Radiographs, per the surgeon appears to demonstrate lucency about the tibial plateau component of the prosthesis and femoral component of the prosthesis on the left that may represent loosening.Medical records and clinical history were provided.It is unknown if the patient underwent revision of the left knee or if a left knee revision is planned or scheduled.The patient was referred to an orthopaedic surgeon for consultation of possible revision.No additional information is available.

• Brand Name: CR TIBIAL INSERT SZ 1, 11MM
• 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: julia goldberg ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 25450349
• Report Number: 1038671-2026-00749
• Device Sequence Number: 10363377
• Product Code: JWH
• UDI-Device Identifier: 10885862040152
• UDI-Public: 10885862040152
• 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: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 04/09/2018
• Device Catalogue Number: 200-21-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 04/10/2010
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White