MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 9 MM

Model Number	02-012-49-2509
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
Revision knee due to infection.
Event or Problem Description
This 82 y/o male patient was initially implanted on (b)(6) 2016.Approximately 3 years post-operatively, this current revision knee is due to infection was on (b)(6) 2019.All available information has been received at this time.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the subsequent revision cannot be conclusively determined since the devices were not returned; however, it is most likely is related to the patient conditions.
Additional Manufacturer Narrative
The evaluation noted that this 82 y/o male patient was initially implanted on (b)(6) 2016.Approximately 3 years post-operatively, this current revision knee is due to infection was on (b)(6) 2019.All available information has been received at this time.Knee infection: infection is found to be one of the most serious complications after total knee arthroplasty.Currently the incidence of prosthetic knee infection is 1-3%, antibiotic prophylaxis is the most effective method of prosthetic joint infection.Knee joints are susceptible to infection due to the following: scant muscle coverage, pre-existing conditions of the patient (immunosuppression, rheumatoid arthritis, diabetes mellitus, and obesity).It was also found that increased rates of infection were seen in septic arthritis increased the risk of infection if prosthesis were implanted in that joint and prior surgical interventions to the primary prosthetic implant.1 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.2,3 based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the subsequent revision cannot be conclusively determined since the devices were not returned; however, it is most likely is related to the patient conditions.References 1.Martinez-pastor, j.M.-b.-v.(2019).Acute infection in total knee arthroplasty: diagnosis and treatment.13.The open orthopaedics journal.Retrieved february 5, 2019, from https://benthamopen.Com/fulltext/toorthj-7-197 2.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: 1594-9.3.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.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 9 MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9250312
• Report Number: 1038671-2019-00544
• Device Sequence Number: 2310677
• Product Code: JWH
• UDI-Device Identifier: 10885862159212
• UDI-Public: 10885862159212
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 06/06/2022
• Device Model Number: 02-012-49-2509
• Device Catalogue Number: 02-012-49-2509
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention