Catalog Number 101214070 |
Device Problems
Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Distress (2329); Metal Related Pathology (4530); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577)
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Event Date 01/25/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Event Description
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Pinnacle mom litigation records received.Litigation alleges heavy metal poisoning from toxic heavy metals, muscle, tissue, scar tissue formation, pain, metallosis, metal wear, limited adl, distress and emotional trauma.Doi: (b)(6) 2009; dor: (b)(6) 2023; unknown 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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Event Description
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Updated event description: during the revision procedure, significant cloudy joint effusion consistent with reaction to a metal-on-metal bearing.Small amount of corrosion at the head neck junction on the stem, well fixed components, large anterior osteophyte.The hip was aspirated of cloudy joint fluid consistent with a metal-on-metal bearing.There was some synovitis, consistent with a metal-on-metal bearing.Doi: (b)(6) 2009, dor: (b)(6) 2023, affected side: left hip.
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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 information received, will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed.And the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre) was not possible, because the required lot code was not provided.Added: b1: (product problem), h6: health effect: clinical code.Corrected: h6: medical device problem code.
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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.H10 additional narrative: added: g4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D1, d2, d4 and d10.
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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 - according to the information received, "pinnacle mom litigation records received.Litigation alleges heavy metal poisoning from toxic heavy metals, muscle, tissue, scar tissue formation, pain, metallosis, metal wear, limited adl, distress and emotional trauma.The product was not returned to depuy synthes, however photos were provided for review.See attachment "(b)(6) 2023 img1.Png, (b)(6) 2023 img2.Png".The device associated with this report was not returned to depuy synthes for evaluation.The x-rays attached were reviewed, however the x-rays does not provide enough evidence to confirm the alleged reported condition.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs attached are insufficient to draw a conclusion about the reported event.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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