MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	200-23-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical devices: 200-02-35 - three peg patella 35mm 1125187, 200-04-33 - cemented finned tib.Tra sz 3f/3t 1123412, 201-46-10 - holding pin headless 3" (4 pk) 1069191, 230-02-03 - optetrak asy,cr cemented femoral, sz 3, 1103473, 620-00-02 - platelet rich plasma kit with spray tips 90403, 620-11-02 - accelerate conc.Sys rep by 620-12-02 6011140703.
Event or Problem Description
As reported, the patient had an initial tka in 2008.The patient presented with pain and was revised and a new insert implanted.The surgeon noted some synovitis and some poly wear.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of pain and prosthesis wear after being implanted for over 12 years.However, this cannot be confirmed as the device was not returned for evaluation and images/radiographs 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: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: c, d, e, g.The revision reported may have been the result of pain and prosthesis wear after being implanted for over 12 years.However, this cannot be confirmed as the device was not returned for evaluation and images/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 SZ3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15624053
• Report Number: 1038671-2022-01313
• Device Sequence Number: 6224302
• Product Code: JWH
• UDI-Device Identifier: 10885862040244
• UDI-Public: 10885862040244
• 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: 2008
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2025

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: 06/30/2010
• Device Model Number: 200-23-09
• Device Catalogue Number: 200-23-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 05/15/2023; 01/07/2025
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 05/31/2023; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2002
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male