Catalog Number 136551000 |
Device Problems
Naturally Worn (2988); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Unspecified Tissue Injury (4559)
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Event Date 11/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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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(b)(6) 2019: patient received a left total hip due to osteoarthritis.No complications noted.(b)(6) 2023: patient underwent a left hip revision due to intense pain, mobility issues, and squeaking.Intra-op there was a fair amount of metallosis in the capsule.The poly insert was noted to have failed and was cracked in multiple pieces.Due to damage of the cup, the cup was removed with moderate bone loss.There was noted eccentic wear of the femoral head.A competitor cup was placed.
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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.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A complaint database search and/or device manufacturing (dhr) reviews will not be performed.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: a manufacturing record evaluation (mre) will not be performed, since mom systems are obsolete.
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Search Alerts/Recalls
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