Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ambulation Difficulties (2544); Muscle/Tendon Damage (4532); Physical Asymmetry (4573)
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Event Date 01/01/2021 |
Event Type
Injury
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Event Description
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The patient reports that : the surgeon who operated made a mistake in the size of my prosthesis.My operated leg is about 3 cm longer than the other, i have to wear a sole under my shoe + another in my shoe.I walk very badly and can't adapt.I have to return to a rehabilitation center for 6 weeks from (b)(6) 2023.I no longer have balance, tendinitis constantly, i go to the physiologist 2 times a week.
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Manufacturer Narrative
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Product complaint # (b)(4).E3: the initial reporter information has been removed for confidentiality/privacy.The initial reporter is a patient.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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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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