MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PS TIBIAL INSERTS SZ 2, 9MM

Model Number	204-01-02
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Failure of Implant (1924)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.This submission represents 1 of 163 events identified via active surveillance activities utilizing data form the (b)(6) national joint registry ((b)(6)).Follow-ups for additional information cannot be performed for this complaint as the information was submitted as complete by the registry; there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided and it is not possible to obtain any of the devices no information provided in the following section(s): weight, race, and test dates.
Event or Problem Description
As reported by (b)(6) national joint registry ((b)(6)), this (b)(6) y/o, (bmi=28), female patient underwent primary total prosthetic replacement using cement of the right knee via medial parapatellar approach on (b)(6) 2008.The indication for the index procedure was osteoarthritis.On (b)(6) 2017, approximately 108 months post implantation, the patient underwent revision due to infection; other indication for revision; wear of polyethylene component.Follow-ups for additional information cannot be performed for this complaint, information was submitted as complete by the (b)(6) national joint registry ((b)(6)); there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that revision reported was likely the result of infection and prosthesis wear.Based on length of time since implantation, the infection in this case is highly unlikely to be related to the surgical procedure for placement of the total joint or the device itself.However, this cannot be confirmed since the devices were not returned for evaluation.This submission represents 1 of 163 events identified via active surveillance activities utilizing data form the united kingdom national joint registry (uknjr).Follow-ups for additional information cannot be performed for this complaint as the information was submitted as complete by the registry; there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided and it is not possible to obtain any of the devices.

• Brand Name: OPTETRAK
• Common Device Name: PS TIBIAL INSERTS SZ 2, 9MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9708055
• Report Number: 1038671-2020-00119
• Device Sequence Number: 3341452
• Product Code: JWH
• UDI-Device Identifier: 10885862047571
• UDI-Public: 10885862047571
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 06/28/2010
• Device Model Number: 204-01-02
• Device Catalogue Number: 204-22-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 05/08/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR