Catalog Number UNK HIP ACETABULAR LINER |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Inflammation (1932); Muscular Rigidity (1968); Weakness (2145); Ambulation Difficulties (2544); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).(b)(6).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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After review of medical records, visit notes indicated that patient presents with a wound on hip post surgical site.The wound has light to mild serous exudate.It was indicated that the wound was in an inflammatory stage and was unable to progress to a healing phase.Wound was cleansed with clean surgical technique with excision of devitalized tissue including slough, biofilm and non-viable subcutaneous fat.It was also indicated that patient has mild edema, doi: (b)(6) 2019; ; dor: none reported; right 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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Event Description
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After review of medical records, visit notes reported that patient had mild tightness in the hamstring bilaterally, walking difficulty and muscle weakness.
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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.H10 additional narrative: added: b6, b7, h5, h6 (patient).Patient code: no code available (3191) to capture wound secretion.
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Search Alerts/Recalls
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