MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 38MM HUMERAL LINER +0

Model Number 320-38-00

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that a patient had a tsa on (b)(6) 2018.Revision occurred due to infection.

Event Description

It was reported that 1 month postoperatively from a tka, the patient¿s tibial insert was revised due to infection.It was also reported the patient was stable upon leaving the operation room.

Manufacturer Narrative

H10: (h3) it was reported that 1 month postoperatively from a tka, the patient¿s tibial insert was revised due to infection.It was also reported the patient was stable upon leaving the or.The sterile certificates from production of the tibial insert were reviewed and product meets customer specifications; zero nonconformities occurred during this irradiation run.Per ifu# 700-096-004, postoperative counseling and care is important.It is recommended that regular, long-term postoperative follow-up be undertaken to detect early signs of component wear or infection, and to consider the course of action to be taken if such events occur.A suitable rehabilitation program should be designed and implemented.¿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 based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition or is nosocomial in nature.References 1.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.¿ (g5) pma/510(k) number: k063569.(h6) evaluation codes: 1735, 2993.Section h11: *the following sections have corrected information: (b5) it was reported that 1 month postoperatively from a tka, the patient¿s tibial insert was revised due to infection.It was also reported the patient was stable upon leaving the operating room.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9104146
• MDR Text Key: 162987375
• Report Number: 1038671-2019-00463
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2023
• Device Model Number: 320-38-00
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention