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Catalog Number 110005273 |
Device Problems
Material Erosion (1214); Device Dislodged or Dislocated (2923)
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Patient Problem
Metal Related Pathology (4530)
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Event Date 07/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Product code: phx.Concomitant products: comp conv glen liner e1 cat# 110005237 lot# 375420.Versa-dial 46x18x53 hum head cat# 113042 lot# 020990.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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: 0001825034 - 2021 - 02457 , 0001825034 - 2021 - 02458.
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Event Description
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It was reported that a patient underwent a revision procedure approximately 30 months post implantation due to disassociation of the glenoid poly and baseplate.Metallosis occurred between the baseplate and humeral head due to the disassociation.Poly and humeral head were removed and patient was converted to reverse.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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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: b4, b5, g3, g6, h2, h3, h6, h10 visual inspection of the returned products to verify item and lot numbers.Inspection of each product found them to be damaged and worn.Lot 020990 has a been assembled with a component part (lot 118001).Wear marks and discoloration was found on lot 020990.Inspection of lot 375420 found the part to be fractured and not all the pieces were returned.There was also an unknown blue screw returned with a piece of poly still attached to it.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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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Search Alerts/Recalls
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