Model Number 1517-60-112 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Fall (1848)
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Event Date 11/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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It was reported that the patient fell and broke his tibia.In doing so, he split open his incision and surgeon chose to wash it out.Insert and pin (femur not exchanged) were exchanged after thorough i & d and placement of antibiotic beads.Doi: (b)(6) 2020, dor: (b)(6) 2020, right knee.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was returned, but an x-ray has been received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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