Model Number 115395 |
Device Problem
Difficult to Insert (1316)
|
Patient Problem
Ossification (1428)
|
Event Date 05/25/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Cmp (b)(4).G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that approximately 10 years post implantation of a total shoulder arthroplasty, the patient was revised due to disassociation of the baseplate.During the procedure, it was also noted that the central screw had backed out.The surgeon then drilled for a new central screw and was unable to get the screw to be positioned properly due to alleged boney ingrowth into the baseplate.The surgeon decided to proceed without placement of a central screw, as the baseplate was allegedly well-fixed.Attempts for additional information have been made and none has been provided.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.X-ray is provided for linked complaint and will be evaluated there.The root cause of the reported issue is attributed to user error.It was reported the screw was not fully seated in the first surgery.The surgical technique gives instructions on how to verify that the screw is seated.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
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|