Catalog Number 00434906603 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Erosion (1750); Failure of Implant (1924)
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Event Date 12/05/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 12mm humeral stem spacer cat#00434903912, lot#62952482.Foreign: canada.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: 0001822565-2022-03572.
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Event Description
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It was reported that a patient underwent a revision procedure approximately 2.5 years post implantation due to liner disassociation.During the procedure, scapular notching was noted as well as a deformed liner locking mechanism.The poly liner, spacer, and glenosphere were exchanged.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.D10: 12mm humeral stem spacer cat# 00434903912 lot# 62952482.15mm post length base plate cat# 00434901500 lot# 64428911.40mm ã¿ glenosphere cat# 00434904011 lot# 64503726.Visual examination of the returned product identified a zimmer tm reverse shoulder retentive poly liner (lot 64374987) and a zimmer tm reverse shoulder humeral stem spacer (lot 62952482) were returned.As returned, damage is seen on the rim feature of the spacer.The poly liner exhibits damage to the backside, locking tabs, and rim feature.No glenosphere or baseplate 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: a reverse-type left shoulder arthroplasty is present with glenohumeral dislocation.There is no fracture or evidence of implant loosening.Bone quality appears osteopenic.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 is available at the time of this report.
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Search Alerts/Recalls
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