Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Muscle/Tendon Damage (4532)
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Event Date 11/16/2023 |
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.E3 initial reporter occupation: lawyer 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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Update ad medical records 9 apr 2024 reviewed: on (b)(6) 2023, patient presented with constant soreness, anterior and lateral pain, occasional numbness in her feet, popping in her hip with rotation, and aggravation of her pain with prolonged sitting/standing/walking.She had had one episode of shooting pain while walking.She also complained that her right hip was no beginning to ¿bother her¿.On (b)(6) 2023, the patient was seen by a joint specialist for her symptoms, which further included occasional groin pain when walking and a sharp pain with ¿happens quickly and then subsides¿.The specialist recommended ultrasound injection for treatment of possible psoas tendinitis (it is unclear if she received this treatment).Patient is seeking a legal claim due to the failure of her hardware (the fractured polyethylene liner), but at the time of this record, there was no formal litigation.Doi: (b)(6) 2019 ( stem & cup ) doi: (b)(6) 2022 ( head & liner ) doe: (b)(6) 2023 this is a link of (b)(4).
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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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