Catalog Number 961673 |
Device Problems
Disassembly (1168); Naturally Worn (2988)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (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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Revision total knee replacement dr (b)(6); (b)(6) hospital (b)(6) 2018.During use on patient, femoral torque wrench lodged on adaptor prosthesis, wrench very visually worn.Wrench struck with mallet and osteotomes to dislodge it in order to manage problem during procedure.10 mins delay to procedure, ae to patient, female patient initials (b)(6) date of birth (b)(6).
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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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Manufacturer Narrative
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Product complaint # pc-(b)(4).Investigation summary the reported device was not returned to the investigation site for evaluation.The reported device has been evaluated at the australia facility and the reported event was confirmed.The black end cap was also noted to be missing.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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