|
Catalog Number 320-01-46 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Joint Disorder (2373)
|
Event Type
Injury
|
Manufacturer Narrative
|
In a review of the labeling it is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.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 instability of the left shoulder joint devices is most likely related to the patient's underlying conditions to include previous significant shoulder maladies.This device is used for treatment, not diagnosis.No information: serial and expiration date.
|
|
Event Description
|
It was reported through clinical data collection activities that a patient experienced device instability to the left shoulder with an onset of (b)(6) 2018 that required revision surgery on (b)(6) 2018.The revision marked the event as being as "resolved".The patient had described a history of at least 3-5 anterior instability, as subluxations that were self-reduced.The patient has significant medical history for left shoulder surgeries and/or injuries.There is no indication that the device malfunctioned.No additional information is provided.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00471, 1038671-2019-05000, 1038671-2019-05001, and 1038671-2019-05003.
|
|
Search Alerts/Recalls
|
|
|