Catalog Number 999890249 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Synovitis (2094); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Metal Related Pathology (4530); Swelling/ Edema (4577)
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Event Date 07/10/2020 |
Event Type
Injury
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Event Description
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Asr litigation complaint received ad (b)(6) 2022.Litigation records alleges pain, discomfort, increased metal level in blood including cobalt and chromium, injury, emotional distress, disability, disfigurement and economic changes.Doi: mar.2007 dor: (b)(6) 2020.Left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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.
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Event Description
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After review of medical records patient was revised due to wear of articular bearing surface of internal prosthetic left hip joint.Operative notes indicated soft tissue mass approximately 12cm diameter beginning at the distal aspect prior to incision extending distally.The mass was incised gently and there was egress of copious amounts of cloudy milky fluid which was suctioned.Mri showed cystic soft tissue mass extending through the fascia to the hip.There was mild to moderate dark staining of the synovial tissue and minimal trunnionosis.
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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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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.
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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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Pfs alleges pseudotumors and metallosis.
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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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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: previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Therefore, no dhr (device history record) review for this individual asr component will be carried out at this point in time.
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Search Alerts/Recalls
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