EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
|
Back to Search Results |
|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Implant Pain (4561)
|
Event Date 10/27/2022 |
Event Type
Injury
|
Event Description
|
It was reported that we received images from a surgeon following a discussion regarding the device recall with an engineer.The patient presented with right knee pain.The devices reported were logic components and trapezoidal tibial trays.No additional information is available.
|
|
Manufacturer Narrative
|
Additional information, including the product investigation, will be submitted within 30 days of receipt.
|
|
Manufacturer Narrative
|
H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of pain and the subsequent revision cannot be conclusively determined; however it is most likely related to patient conditions as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.
|
|
Search Alerts/Recalls
|
|
|