Model Number L20312 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Joint Laxity (4526); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)
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Event Date 09/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).(b)(4).Initial reporter occupation: lawyer.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 pfs and medical records received.Pfs alleges pain, sleeping disturbance, discomfort right leg, hip, walking difficulty and instability.Miss out work due to hip pain, surgery and recovery.Plaintiff is seeking compensation for all the injuries and financial losses.After review of the medical records the lab result mri hip reported there was a streak artifact despite metal artifact reduction.There is a mild atrophy of the right iliopsoas and hamstring tendinopathy.Mild degenerative arthrosis of the symphysis pubis and pubalgia.Cobalt and chromium result were below 7 ppb.Doi: (b)(6) 2010; dor: (b)(6) 2019; right 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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot = > a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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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, b6, d4 (procode,lot,udi), g4, h4 and h6 (patient) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2, d3, d10, g1 and h6 (patient).
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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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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