Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Pain (1994); Insufficient Information (4580)
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Event Date 10/16/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision procedure for unknown reasons.No additional information has been provided at this time.
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Manufacturer Narrative
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(b)(4).D10: 00612005828 item name liner 28 mm i.D.For use with 58 mm o.D.Shell 20 deg.Elevated rim lot # 40251808.32-8333-055-00 item name cpt centralizer pmma pkgd lot # 54786900.00-6200-058-22 item name f/m acet shell 58mmod cluster lot # 15234700.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports 0001822565 - 2023 - 03100.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.
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Event Description
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It was reported that the patient underwent a revision procedure post implantation due to pain and eccentric wear.The head and liner were replaced.There is no additional information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b4.G3.G6.H2.H6 proposed component code: mechanical (g04)- head.H10.Visual examination of the provided pictures identified wear to the inner and outer rim of the liner.No damage was noted to the outer spherical surface of the head.No further evaluation can be made from the provided pictures.Review of the device history records identified no deviations or anomalies during manufacturing.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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There is no update to the prior event description provided.
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Search Alerts/Recalls
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