MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 4, 11MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	200-64-11
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: (b)(6), 200-02-35 - three peg patella 35mm.(b)(6), 200-04-44 - cemented finned tib.Tra sz 4f/4t.(b)(6), 230-02-04 - optetrak asy,cr cemented femoral, sz 4.
Event or Problem Description
As reported via legal documentation, on (b)(6)2012, this patient underwent left total knee replacement surgery and was implanted with an exactech knee system.In the ensuing time, the patient began to suffer from symptoms including severe osteolysis, pain and lack of mobility.As a result of these symptoms, patient underwent a left knee revision surgery on (b)(6)2022, approximately 10 years after their initial procedure.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
H6: investigation results - the revision reported was likely the result of osteolysis, pain, and lack of mobility after being implanted for approximately 10 years as stated in the legal documentation.The extent and root cause of the reported osteolysis cannot be determined as the device was not returned for evaluation, and images, radiographs, and operative notes were not provided.

• Brand Name: CR TIBIAL INSERT SZ 4, 11MM, SLOPE +
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: kate jacobson ; 3523782617
• MDR Report Key: 16913247
• Report Number: 1038671-2023-00973
• Device Sequence Number: 14048853
• Product Code: JWH
• UDI-Device Identifier: 10885862041111
• UDI-Public: 10885862041111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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
• Device Expiration Date: 07/19/2014
• Device Model Number: 200-64-11
• Device Catalogue Number: 200-64-11
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2009
• 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 Sex: Unknown