Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)
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Patient Problems
Tissue Damage (2104); Test Result (2695); Not Applicable (3189); No Code Available (3191)
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Event Date 05/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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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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User facility report received.It was stated that the revision of left total hip with exchange of acetabular liner and head.Elevated cobalt levels consistent with adverse reaction to metal.Findings: large debris pseudo-tumor, black corrosion material at head neck junction.Doi: (b)(6) 2009; dor: (b)(6) 2018 left hip.
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Manufacturer Narrative
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(b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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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Search Alerts/Recalls
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