Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problems
Fall (1848); Joint Dislocation (2374); Subluxation (4525)
|
Event Date 12/01/2021 |
Event Type
Injury
|
Event Description
|
It was reported that after the patient had an initial right total hip arthroplasty the patient experienced dislocation and subluxation resulting in closed repositioning.No further compilations have been reported and the patient remains very satisfied with his new joint at this time.There is no additional information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: item #: 010000851 item name: g7 neutral e1 liner 32mm g lot number: 3387421.Item #: 192015 item name: echo por fmrl nc 15x155mm lot number: 534880.Item #: 010000667 item name: g7 pps ltd acet shell 60g lot number: 3441508.Unk lot unk apical plug.Report source: foreign: denmark.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00037.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Head - review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: dislocation and subluxation, closed repositioning on (b)(6) 2021.No issues, pain, or discomfort on (b)(6) 2022.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
|
There is no update to the previous event description provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.
|
|
Event Description
|
It was reported that the patient underwent a revision procedure 8 years and 1 month post implantation due to recurrent dislocation and subluxation.The head and liner were exchanged.There is no additional information available at the time of this report.
|
|
Search Alerts/Recalls
|