MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PS TIBIAL INSERTS SZ 1, 11MM

Model Number	204-01-00
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/13/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.No information provided in the following section(s): weight, ethnicity, and relevant test/lab.This submission represents 1 of 163 events identified via active surveillance activities utilizing data form (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.
Event or Problem Description
As reported by (b)(6), this (b)(6) y/o (bmi=30), female patient underwent primary total prosthetic replacement using cement of the right knee via medial parapatellar approach on (b)(6) 2009.The indication for the index procedure was osteoarthritis.On (b)(6) 2014, approximately 57 months post implantation, the patient underwent revision due to implant fracture, infection, other indication for revision, and wear of polyethylene component.Follow-ups for additional information cannot be performed for this complaint, information was submitted as complete by (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.Infection is a clinically well-known potential complication of any surgical procedure including knee arthroplasty.If infection occurs after knee replacement, whether related to the procedure or otherwise, the foreign metal and plastic implants can serve as a surface for the bacteria to latch onto, inaccessible to antibiotics.Even if the implants remain well fixed, the pain, swelling, and drainage from the infection make the revision surgery necessary.With current surgical techniques and antibiotic regimens, the rate of infection following total knee arthroplasty ranges from 0.4% to 2.5%.1 the highest risk period for infection is between six months and three years.P.B.Voleti, k.D.Baldwin, and gwo-chin lee.¿use of static or articulating spacers for infection following total knee arthroplasty: a systematic literature review¿.The journal of bone and joint surgery.Sept 2013; 95-a: 1594-9.2.J.B.Meding, m.A.Ritter, k.E.Davis, and a.Farris."meeting increased demand for total knee replacement and follow-up: determining optimal follow-up".The bone and joint journal.Nov 2013; 95-b: 1484-9.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that revision reported was likely the result of a combination of infection as well as patient conditions which resulted in polyethylene wear and implant fracture.However, this cannot be confirmed since the devices were not available 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 1, 11MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9709875
• Report Number: 1038671-2020-00137
• Device Sequence Number: 16868371
• Product Code: JWH
• UDI-Device Identifier: 10885862047557
• UDI-Public: 10885862047557
• 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: 2009
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 07/04/2010
• Device Model Number: 204-01-00
• Device Catalogue Number: 204-01-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 12/02/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR