Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Limb Fracture (4518); Joint Laxity (4526)
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Event Date 06/09/2023 |
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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Hcp reported two consecutive revisions of hip pe-inlays.This complaint is about the first revision.Hcp reported two consecutive revisions of hip pe-inlays.This complaint is about the first revision.The patient fell on her back and buttocks on (b)(6) 2022 and had no issues until (b)(6) 2023 when she began to have pain in the left hip.X-rays showed the femoral head was off center with suspicion of a dislocation.During the revision, joint instability, synovitis, metallosis, a fractured inlay, and dislocation of the head and liner was identified.There were two healed fractures identified ¿ likely caused from the fall previously.Doi: (b)(6) 2021.Dor: (b)(6) 2023 (head/liner only).
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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.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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Additional information was received: upon further investigation on (b)(6) 2024, it was discovered, from the x-ray images, that the liner and cup has disassociated based on the positioning of the head inside the cup.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: according to the information received."hcp reported, two consecutive revisions of hip pe-inlays.This complaint is about the first revision".The product was not returned to depuy synthes.However, photos were provided for review.The device associated with this report was not returned to depuy synthes for evaluation.The photographs attached were reviewed.However, nothing indicative of a device nonconformance was observed.Since, the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed.As the observed, condition of the unknown hip femoral stem would not contribute to the reported adverse event.Based on the investigation findings, it has been determined, that no corrective and/or preventative action is proposed.There is no indication, that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.
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Search Alerts/Recalls
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