Catalog Number 101204020 |
Device Problem
Defective Device (2588)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 10/16/2017 |
Event Type
malfunction
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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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It was reported that the surgeon felt that the implant sat too high and the implant was too big.It was also stated that they removed and rebroached and placed a new size 2 triloc bps.
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Manufacturer Narrative
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Product complaint # pc-(b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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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Complaint description: it was reported that the surgeon felt that the implant sit too high and the implant was too big.It was also stated that they removed and rebroached and placed a new size 2 triloc bps.
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Search Alerts/Recalls
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