Device Problems
Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Osteolysis (2377); Impaired Healing (2378)
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Event Date 09/23/2016 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Index surgery: (b)(6) 2016.Reoperation to excise tuberosities due to tuberosity resorption.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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Device part# 320-10-00.It is known complication that revision surgeries occur.Also, as part of the pre-operative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and or the postoperative period.There is no indication that there is a device related problem/malfunction, there is no allegation against any device.The most likely cause of the reported event is related to the underlying conditions of the patient.This device is used for treatment not diagnosis.
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Event Description
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Operation was to the left shoulder.The patient had a follow up (b)(6) 2017 and has had no further complications or complaints.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00111, 1038671-2017-00112, 1038671-2017-00114, 1038671-2017-00115 and 1038671-2017-00116.
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Search Alerts/Recalls
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