|
Device Problem
Unintended Movement (3026)
|
Patient Problems
Failure of Implant (1924); Pain (1994)
|
Event Type
Injury
|
Manufacturer Narrative
|
Patient's age was (b)(6) at time of implant and (b)(6) at follow-up.Patient's exact weight reported as (b)(6).Date of post-operative loosening of the stem and development of pain and tenderness with motion is unknown.This report is for one (1) unknown radial stem.Part and lot numbers are not provided.Without the specific part and lot number, the udi is not available.Not explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that a patient was implanted with an unknown radial head prosthesis on (b)(6) 2015.Initial procedure was completed successfully with no unusual occurrences or surgical delay.Patient had post-operative loosening of the stem, pain and tenderness with motion.The issue was noticed in radiograph x-rays taken on an unknown date upon a follow-up visit.The surgeon plans on revising the patient.A date of revision was not provided.Concomitant devices reported: radial head (part # unknown, lot # unknown, quantity # 1).This report is for one (1) unknown radial stem.This is report 1 of 1 for complaint (b)(4).
|
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It is the opinion of a depuy synthes medical director that "regarding post-op loosening, generally speaking, for this device, we are talking about the stem/bone interface while osteolysis around head area may also be possible.
|
|
Search Alerts/Recalls
|
|
|