Catalog Number 550536008 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); Joint Laxity (4526)
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Event Date 04/17/2024 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that patient was revised due to dislocation.Patient had original surgery done at hospital on (b)(6) 2024.Unfortunately they dislocated and needed to be revised.Surgeon removed the poly, shell, and glenosphere.A bigger glenosphere was implanted to increase stability.There was no adverse events or delays took place.Doi: (b)(6) 2024.Dor: unknown.Affected side: left shoulder.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description:- 550536008.Product code:- glenosphere 36+8.Lot no:- 333112.Quantity manufactured:- (b)(4) pieces.Date of manufacturing:- finished production ¿ 9/12/2022, micropulse clean/pack ¿ 10/31/2022, sterigenics ¿ 11/3/2022.Released from m.P.On 11/7/2022.Any anomalies or deviations identified in dhr:- started product with (b)(4) pieces with 2 pieces scrapped at set-up at first mill operation.Finished the rest of the operations with no scrap and no quality issues for a finished total of (b)(4) pieces.Expiry date:-- n/a ¿ micropulse label states 8/31/2027.Ifu reference:- n/a.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: product description:- 550536008.Product code:- glenosphere 36+8.Lot no:- 333112.Quantity manufactured:- (b)(4) pieces.Date of manufacturing:- finished production ¿ 9/12/2022, micropulse clean/pack ¿ 10/31/2022, sterigenics ¿ 11/3/2022.Released from m.P.On 11/7/2022 any anomalies or deviations identified in dhr:- started product with (b)(4) pieces with 2 pieces scrapped at set-up at first mill operation.Finished the rest of the operations with no scrap and no quality issues for a finished total of (b)(4) pieces.Expiry date:-- n/a ¿ micropulse label states 8/31/2027.Ifu reference:- n/a.Device history batch: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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