Model Number N/A |
Device Problem
Positioning Failure (1158)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 12/27/2023 |
Event Type
Injury
|
Event Description
|
It was reported that the patient underwent an initial hip procedure on an unknown date.Subsequently, the patient was revised as the implanted screw appeared to have gone through the screw hole of the cup.Attempts have been made and no further information has been provided.
|
|
Manufacturer Narrative
|
(b)(4).D10: cat# 00625006520 lot# j8520777 bone scr 6.5x20 self-tap.Cat# 00625006530 lot# j7464080 bone scr 6.5x30 self-tap.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.
|
|
Event Description
|
No further information at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the right hip arthroplasty.Passage of an acetabular fixation screw through the screw aperture as noted.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
|
No further information at the time of this report.
|
|
Search Alerts/Recalls
|