EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
|
Back to Search Results |
|
Model Number LOGIC TIBIA PS MOD INSRT SZ 5 9MM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 12/19/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: serial #: (b)(4), catalog #: 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t; serial #: (b)(4), catalog #: 200-02-38 - three peg patella 38mm; serial #: (b)(4), catalog #: 02-010-01-0350 - logic femoral ps cem right sz 5.Additional information, including the product investigation, will be submitted within 30 days of receipt.
|
|
Event Description
|
It was reported via a legal notification that a male patient, initial right knee implanted on (b)(6) 2015, presented to their joint replacement institute for reasons unknown.Examination was performed and x-rays were taken.It was determined that the plaintiffs optetrak® device is failing at a much faster rate than expected making the artificial knee joint more prone to wearing out, loosening, and causing pain, muscle, nerve, and bone damage.This also significantly increases the likelihood that the joint will break.The plaintiff's surgeon recommended revision surgery to remove and replace the optetrak® device.No further information.
|
|
Manufacturer Narrative
|
H6: investigation results: the reason for the recommended revision cannot be determined, but it may be due to prosthesis wear as reported or may be related to the inclusion of the implanted polyethylene in the packaging recall.However, this cannot be confirmed as the devices are not available for evaluation as they remain implanted and limited information was available at the time of evaluation.
|
|
Search Alerts/Recalls
|
|
|