MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-012-44-5013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
On (b)(6) 2018, a (b)(6) y/o, male patient with a bmi of 44.2, underwent implantation of an insert tib 5 13mm knee post stab cnstrn mod net cmpr mld.On (b)(6) 2018, approximately 8 months post implant, the patient underwent revision due to infection.
Additional Manufacturer Narrative
After further review of additional information received.(h3) 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.Per ifu #700-096-004 - device specific risks - fracture, migration, loosening, subluxation, infection or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.Any ¿surgical site¿ infection noted in a patient that is greater than 3 months postop from a total joint surgical procedure is highly unlikely to be related to the surgical procedure for placement of the total joint or the device itself.(ref 1) it is noted that surgical intervention or revision along with infection is a known risk in any total joint surgery and may result in revision.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10398702
• Report Number: 1038671-2020-00472
• Device Sequence Number: 3168184
• Product Code: JWH
• UDI-Device Identifier: 10885862173737
• UDI-Public: 10885862173737
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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 Model Number: 02-012-44-5013
• Device Catalogue Number: 02-012-44-5013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 57 YR