Model Number 1504-10-108 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)
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Event Date 10/21/2017 |
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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18 may 2018 medical records received.After review of the medical records for mdr reportability, the patient was revised to address a metal allergy to the left total knee replacement.The surgeon reported that the patient "appeared to be allergic to some of the components of the depuy prosthesis¿ the patient also had pain and swelling.Doi: (b)(6) 2016; dor: (b)(6) 2017 (left knee).
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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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: corrected: h6 (device).
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Search Alerts/Recalls
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