MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 9MM, SLOPE +; SEE H10

Model Number	200-62-09
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Discomfort (2330); Implant Pain (4561); Medical device site infection (4845)
Date of Event	05/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer concomitants: 2429019, 200-02-32 - three peg patella 32mm, 2559397, 204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t, 2382142, 230-02-02 - optetrak asy,cr cemented femoral, sz 2, pending investigation.
Event or Problem Description
It was reported from the legal department that on (b)(6) 2017, a patient underwent an irrigation and drainage with polyethylene liner exchange of the left exactech knee device secondary to acute periprosthetic joint infection approximately 34 days after implant.A new exactech optetrak logic tibial insert was implanted.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 - all device finished product release documents were reviewed, the products met specifications for sterilization and distribution.The cause of the subsequent infection and revision cannot be conclusively determined; however, it is most likely associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or any combination of these possibilities.Infection is noted in the ifu as a known implant risk.These devices are used for treatment not diagnosis.There is no other information available.
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: a, b, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of infection or due to inclusion of the polyethylene in the packaging recall.Considering the short implantation time, it is unlikely that the device was worn at the time of revision.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information 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 SZ 2, 9MM, SLOPE +
• 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.; FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16626581
• Report Number: 1038671-2023-00519
• Device Sequence Number: 14769499
• Product Code: JWH
• UDI-Device Identifier: 10885862041029
• UDI-Public: 10885862041029
• 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: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

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: 10/09/2022
• Device Model Number: 200-62-09
• Device Catalogue Number: 200-62-09
• 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: 06/08/2023; 01/27/2025
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 06/08/2023; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2014
• 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: 60 YR
• Patient Sex: Male