Model Number 5552-E-4416 |
Device Problem
Fracture (1260)
|
Patient Problems
Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Implant Pain (4561)
|
Event Date 06/03/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
The information in this report was provided by stryker legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device disposition unknown.
|
|
Event Description
|
It was reported that the patient had her left shoulder replaced on or about (b)(6) 2014 due to osteoarthritis.It is alleged that this resulted in pain in the shoulder and surrounding regions, loss of range of motion and a fracture of the components.It is further alleged that the patient was revised on (b)(6) 2019 and during the surgery the surgeon found the polyethylene glenoid to be completely fractured down the middle.
|
|
Event Description
|
It was reported that the patient had her left shoulder replaced on or about (b)(6) 2014 due to osteoarthritis.It is alleged that this resulted in pain in the shoulder and surrounding regions, loss of range of motion and a fracture of the components.It is further alleged that the patient was revised on (b)(6) 2019 and during the surgery the surgeon found the polyethylene glenoid to be completely fractured down the middle.
|
|
Manufacturer Narrative
|
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
|
|
Search Alerts/Recalls
|