MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ3, 15MM; SEE H10

Model Number	200-23-15
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	06/27/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant: 1734166 200-02-29 - three peg patella 29mm 1976253 230-02-03 - optetrak asy,cr cemented femoral, sz 3, 2013520 204-04-32 - trapezoid tibial tray sz 3f/2t.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.The patient has bilateral knee replacements.These devices are used for treatment not diagnosis.
Event or Problem Description
It was reported via legal documents that on (b)(6) 2011 a female patient underwent a left knee total arthroplasty, then on (b)(6) 2012 the patient underwent a revision of the exactech net compression molded, posterior stabilized tibial insert, and exactech constrained condylar femoral component, approximately 1 year 20 days after implant.It is stated that despite undergoing the revision surgeries, the patient experiences daily knee pain and discomfort which limit activities of daily living and recreation and impacts quality of life.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
This follow-up report is being submitted to relay corrected information.The following corrections have been made: b1, b2, g2 (correcting initial report), g3 (correct initial report to 12-aug-2022), h6: clinical codes, medical device problem code, component code.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, 15MM
• 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: 16640121
• Report Number: 1038671-2023-00542
• Device Sequence Number: 6048789
• Product Code: JWH
• UDI-Device Identifier: 10885862040275
• UDI-Public: 10885862040275
• 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
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2011
• Device Model Number: 200-23-15
• Device Catalogue Number: 200-23-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 02/24/2026; 06/26/2026
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 03/02/2026; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2003
• 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 H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female