|
Model Number N/A |
Device Problem
Positioning Failure (1158)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/27/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Report source: (b)(6).No product was returned, location unknown; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
It was reported the surgeon was preforming a cemented hemi hip arthroplasty for hip fracture.The surgeon reported he prepared the femoral canal with subsequent broaches to accept a size 4 cpt stem.The nurse prepared the cement, and the surgeon attempted to attach the size 4 cpt stem to the inserter.He noted difficult in treading the stem onto the inserter, and was not confident with the attachment.The surgeon introduced cement into the femoral canal and attempted to insert the stem.The stem would not completely seat, and the handle disassociated from the inserter.The surgeon attempted to use another instrument to insert the stem but was unable to completely seat the stem to the desired height.The surgeon removed the size 4 stem and removed the cement and re prepared the surgical canal for a secondary stem insertion.No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|
|
|