MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 11MM; SEE H10

Model Number	208-23-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094)
Date of Event	11/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty revision on (b)(6) 2007 and then approximately 15 years, 7 months later had a surgical revision on (b)(6) 2022.The patient had simultaneous knee replacements and revision procedures.Revision operative report of (b)(6) 2022- the femoral and tibial components were very well fixed.Polyethylene liner exchange done.Left side upsized to 13mm cck.The patella component demonstrated wear and was revised.There was a moderate degree of inflamed and thickened synovium consistent with chronic synovitis.The patellar component was not loose but had polyethylene wear.There was wear on the anterior aspect of the box for the tibial insert.Procedure: there was thickened inflamed synovium consistent with polyethylene particulate debris-induced process.A sterile dressing was applied to the knee and the patient taken to recovery in stable condition.Hospital care: admitted (b)(6) 2022/discharged (b)(6) 2022.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
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.

• Brand Name: CC TIBIAL INSERT SZ 3, 11MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17200154
• Report Number: 1038671-2023-01459
• Device Sequence Number: 5768349
• Product Code: JWH
• UDI-Device Identifier: 10885862054258
• UDI-Public: 10885862054258
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• 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): 10/25/2024

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: 09/26/2011
• Device Model Number: 208-23-11
• Device Catalogue Number: 208-23-11
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2006
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female