Model Number 1513-16-060 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Low Blood Pressure/ Hypotension (1914); Dizziness (2194)
|
Event Date 06/05/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).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 physical therapy notes and progress notes (b)(6) 2021 indicate the patient felt unwell and lightheaded multiple times with one brief loss of consciousness due to orthostatic hypotension post revision procedure ¿ treated with bolus of 500 ml normal saline per episode.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).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 physical therapy notes and progress notes (b)(6) 2021 indicate the patient felt unwell and lightheaded multiple times with one brief loss of consciousness due to orthostatic hypotension post revision procedure ¿ treated with bolus of 500 ml normal saline per episode.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4) investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Search Alerts/Recalls
|