Catalog Number 110010267 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Erosion (1750); Osteolysis (2377)
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Event Date 11/01/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a left hip procedure approximately nine months¿ post implantation due to osteolysis and loosening.During the procedure, bone loss was noted, the shell was removed and replaced.Attempts have been made and no further information is available.
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Manufacturer Narrative
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(b)(4).Report source: australia.Concomitant medical products: cat #: 31-323240/3.2mmx40mm rnglc+ acet drl bit/ lot #: 614350 cat #: ep-200152/act artic e1 hip brg 28x46mm/ lot #: 735920 cat #: 110024465/g7 dual mobility liner 46mm g/ lot #: 492650 cat #: 00625006550/bone screw self-tapping 6.5 mm dia.50 mm length/ lot #: 63794457.Cat #: 00625006520/bone screw self-tapping 6.5 mm dia.20 mm length/lot #: 64615051.Cat #: 00625006520/bone screw self-tapping 6.5 mm dia.20 mm length/lot #: j6963834.Cat #: 00625006540/bone screw self-tapping 6.5 mm dia.40 mm length/lot #: j6923630.Cat #: 00625006525/bone screw self-tapping 6.5 mm dia.25 mm length/lot #: j6925770.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
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Manufacturer Narrative
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(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 related to the reported event.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.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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