Model Number N/A |
Device Problems
Entrapment of Device (1212); Malposition of Device (2616); Positioning Problem (3009)
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Patient Problems
No Information (3190); No Code Available (3191)
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Event Date 10/30/2015 |
Event Type
Injury
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Manufacturer Narrative
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This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in (b)(6) manufactures a similar device in the united states under 510k number (b)(4).
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Event Description
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It was reported that patient underwent a right total hip arthroplasty on (b)(6) 2015.Subsequently, a revision procedure was performed on (b)(6) 2015 due to impingement.The acetabular cup was removed and replaced.
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Manufacturer Narrative
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This follow-up report is being filed to correct and relay additional information.This report is number 1 of 3 mdr's filed for the same patient (reference 3002806535-2016-00025, 00385, 00386).Product location unknown.
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Event Description
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It was reported that a patient enrolled in a clinical study underwent a revision approximately 9 months post-implantation due to impingement.During the procedure, the acetabular cup was removed and replaced.
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Search Alerts/Recalls
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