Catalog Number UNK HIP FEMORAL STEM SUMMIT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Inflammation (1932); Pain (1994); Synovitis (2094); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
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Event Type
Injury
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Event Description
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Pinnacle mom hip medical record received.After review of the medical records, clinical visit reported left hip pain, elevated metal ions, scar sensitivity and scar neuromas.Mri reported for the left hip had small hip effusion, tendinosis on the trochanter and bursitis.Doi: (b)(6), 2007.Dor: unrevised ; left hip.
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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 h6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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).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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On (b)(6) 2022, mri notes, left hip arthroplasty, synovial cyst, small left hip effusion, synovitis.Right hip arthroplasty and moderate hip effusion.
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Search Alerts/Recalls
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