Catalog Number UNK SHOULDER HUMERAL CUP DELTA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Unspecified Tissue Injury (4559)
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Event Date 10/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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 the patient had the right shoulder replaced five years ago where they received a delta extend reverse shoulder construct.Patient recently came to doctor because of right shoulder pain, x-rays revealed that could be a steel lysis.It¿s severe bone loss around the implants.Doctor revise the shoulder, explanted and metaglene component, glenosphere, four screws, and the proximal body.The lot numbers for the humeral cup and the four screws were illegible.The humerus stem was left in situ, and a new proximal body was put on.Because of the severe bone loss in the glenoid, a cta head was utilized.Doi: unknown dor: (b)(6) 2023 affected side: right should.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
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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.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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: the device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.
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Search Alerts/Recalls
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