Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant products: unk reverse glenosphere cat#ni lot#ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 01074.
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Event Description
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It was reported that a patient underwent a revision procedure approximately 6 months postimplantation due to disassociation.The glenosphere and poly were replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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It was reported that a patient underwent a revision procedure approximately 18 months post implantation due to disassociation.The glenosphere and poly were replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
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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 corrected: e1, b3, the following sections were updated: b4, b5, g3, g6, h2, h10.
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Event Description
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No further event information is 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.The following sections were updated: d2: phx.D10: glenosphere centric 40mm diameter +0 mm lateral offset cat#00436004000 lot#64439968.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is no acute fracture or evidence of implant loosening.However, the glenosphere is displaced from the metaglene with resulting subluxation but no frank dislocation.It was identified that during the procedure an incorrect impactor was used; however, after further review with development it was determined that this did not cause or contribute to the disassociation reported.Therefore the root cause for the reported event remains unknown.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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Search Alerts/Recalls
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