Catalog Number 136511500 |
Device Problems
Naturally Worn (2988); Noise, Audible (3273)
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Patient Problems
Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 08/24/2015 |
Event Type
Injury
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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.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.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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Pinnacle litigation complaint received ad 17 aug 2023.On (b)(6) 2015 patient underwent a revision surgery due to severe pain, discomfort, inflammation, squeaking, elevated cobalt and chromium levels, friction and wear between the metal head and metal liner caused large amounts of toxic cobalt chromium metal ions.During the procedure, it was further discovered that she had developed significant metallosis around the hip with accompanying tissue damage.Doi: (b)(6) 2008.Dor: (b)(6) 2015.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 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.H10 additional narrative:.
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Event Description
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Medical records were received: after review of the medical records the patient was revised to address adverse local tissue reaction metal on metal bearing, elevated metal ions and hip pain.Operative note reported there was a dishwater type fluid from the joint, surgical delay due to metal liner difficult to disengage.On (b)(6) 2023 mri spine, muscle spasm and left leg weakness.However there was no invasive treatment or revision noted.Doi: (b)(6) 2008; dor: (b)(6) 2015: left 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).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 litigation complaint received ad 17 aug 2023.On (b)(6) 2015 patient underwent a revision surgery due to severe pain, discomfort, inflammation, squeaking, elevated cobalt and chromium levels, friction and wear between the metal head and metal liner caused large amounts of toxic cobalt chromium metal ions.During the procedure, it was further discovered that she had developed significant metallosis around the hip with accompanying tissue damage." the product was not returned to depuy synthes, however photos were provided for review.See attachment ((b)(4) _x-ray_images-received 31-jan-2024).The x-ray investigation revealed that there were no product problems observed with articuleze m 28mm 1.5 the overall complaint was unconfirmed as the observed condition of the articuleze m 28mm 1.5 would not contribute to the complained device issue.Based on the investigation findings, and 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: 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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