MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number 02-012-44-2513

Device Problem Degraded (1153)

Patient Problem Failure of Implant (1924)

Event Date 05/28/2018

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

On (b)(6) 2018, a (b)(6) y/o, female patient with a bmi of 19.7, underwent implantation of a insert tib 2.5 13mm knee poststab cnstrn mod net cmpr mld.On (b)(6) 2018, approximately 0 months post implant, the patient underwent revision due to polyethylene exchange.

Manufacturer Narrative

After further review of additional information received the following sections g3, g4, g7, h2 and h3 have been updated accordingly.(h3) upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is patient conditions.In a review of the labeling and ifu 700-060-004, it is a known complication that excessive activity and trauma affecting joint replacements have been associated with premature failure.Also, fracture, migration, loosening, subluxation or dislocation of the prosthesis or any of its components, and any of which could require intervention or revision.And may require a second surgical intervention or revision.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10393999
• MDR Text Key: 202515130
• Report Number: 1038671-2020-00456
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K110547
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02-012-44-2513
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 73 YR