Catalog Number 999800756 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Inflammation (1932); Nerve Damage (1979); Pain (1994); Synovitis (2094); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 03/01/2023 |
Event Type
Injury
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Event Description
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Litigation asr complaint received ad (b)(6) 2023.Patient was revised was due to pain, discomfort, increased metal ion levels including cobalt and chromium, permanent injuries, emotional distress, disfigurement, disability and economic damages.Doi: (b)(6) 2008.Dor: (b)(6) 2023.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.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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Medical records were received: patient was revised due to acute left pain, suspected fluid collection/ metallosis now abutting the sciatic nerve.Ion levels are quite high, moderate amount reactive synovitis/inflammatory tissue with metal staining consistent with adverse local tissue reaction ( altr ) or metallosis and that this is a known complication with metal on metal implants.Most likely, the stem was left in place.The cup was revised and used a polyethylene bearing.Doi: (b)(6) , 2008 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 - device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.H10 additional narrative: added: a2 (age), b5, b6, h6 (clinical code) corrected: d6a.
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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: a4, b5, b7, h6 health effect - clinical code 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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Medical records received.Patient experienced anxiety due to all the damage that the asr has caused and about any future damage that the high levels and metal in his bloodstream can cause.
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Manufacturer Narrative
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Product complaint # (b)(4) investigation summary: updated on 30 dec 2023: no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.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 reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Unspecified tissue injury (e2015) is being utilized to capture soft tissue injury & bone injury.
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Event Description
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Medical records received.The patient sustained injuries to his tendons, ligaments, tissues, and bones within his hip.The patient suffered from lower back pain and left leg pain.The patient has high cobalt and chromium levels.The surgeon found metallosis.Continue to suffer discomfort and soreness.The patient is anxious about all the damage.
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Search Alerts/Recalls
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