MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; TRULIANT TIB IMP CR INS STD SZ 4, 13MM

Model Number 02-022-47-4013

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erythema (1840); Unspecified Infection (1930); Pain (1994); Joint Swelling (2356)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Patient began experiencing swelling, pain and redness.They came to clinic on (b)(6) 2019 and was prescribed keflex.Knee was aspirated on (b)(6) 2019.Labs found infection and on (b)(6) 2019 the patient had the tibial insert replaced, along with excisional debridement and irrigation and drainage.This case report form indicates that this event is definitely not related to devices or procedure.The case report form indicates this event was resolved with revision surgery on (b)(6) 2019.This event report was received through clinical data collection activities.

Manufacturer Narrative

The evaluation noted that as reported, the 66 y/o male patient was initially implanted with a right tka on (b)(6) 2017.The patient began experiencing swelling, pain and redness and presented to the clinic on (b)(6) 2019 and was prescribed keflex.On (b)(6) 2019, the right knee was aspirated and cultured.Labs found infection and on (b)(6) 2019, the patient had the tibial insert replaced, along with excisional debridement and irrigation and drainage.This case report form indicates that this event is definitely not related to devices or procedure.The case report form indicates this event was resolved with revision surgery on (b)(6)2019.This event report was received through clinical data collection activities.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.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.

Event Description

As reported, the 66 y/o male patient was initially implanted with a right tka on (b)(6)2017.The patient began experiencing swelling, pain and redness and presented to the clinic on (b)(6) 2019 and was prescribed keflex.On (b)(6) 2019, the right knee was aspirated and cultured.Labs found infection and on (b)(6)2019, the patient had the tibial insert replaced, along with excisional debridement and irrigation and drainage.This case report form indicates that this event is definitely not related to devices or procedure.The case report form indicates this event was resolved with revision surgery on (b)(6) 2019.This event report was received through clinical data collection activities.

• Brand Name: TRULIANT
• Type of Device: TRULIANT TIB IMP CR INS STD SZ 4, 13MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9276370
• MDR Text Key: 165199307
• Report Number: 1038671-2019-00558
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862306494
• UDI-Public: 10885862306494
• Combination Product (y/n): N
• PMA/PMN Number: K152170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 02-022-47-4013
• Device Catalogue Number: 02-022-47-4013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 109