Catalog Number UNK HIP ACETABULAR CUP METAL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Seroma (2069); Distress (2329); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 09/08/2021 |
Event Type
Injury
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Event Description
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Litigation records alleges heavy metal poisoning from the toxic heavy metals released by the pinnacle system resulting in injury and requiring surgery to remove the defective hip replacements.Patient was consequently revised due to injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.Additionally, patient suffered pain , injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, incurred additional medical expenses, lost earning potential/ income, and ultimately emotional trauma and distress in the future.Doi: (b)(6) 2007.Dor: (b)(6) 2021.Affected side: unk.
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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 =an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch 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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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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The affected side was the right hip.
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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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : litigation records alleges heavy metal poisoning from the toxic heavy metals released by the pinnacle system resulting in injury and requiring surgery to remove the defective hip replacements.Patient was consequently revised due to injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.Additionally, patient suffered pain , injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, incurred additional medical expenses, lost earning potential/ income, and ultimately emotional trauma and distress in the future.Doi: (b)(6) 2007.Dor: (b)(6) 2021.Affected side: unk.The product was not returned to depuy synthes, however photos were provided for review.Visual inspection of the provided patient x-rays revealed there were no product problems observed with unk hip acetabular cup metal.Based on the provided photo, there was no evidence that suggests the reported adverse vent was due to a product non-conformance.The investigation was not bale to confirm the reported event.The overall complaint was unconfirmed as the observed condition of the unk hip acetabular cup metal would not contribute to the complained device issue.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 : 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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