MAKO SURGICAL CORP. TIBIAL BASEPLATE STD RM/LL SIZE 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Model Number 170615 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size).There was "rm/ll size 5" but it was actually size 6 shape.
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Manufacturer Narrative
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Reported event: an event regarding size/fit issue involving a mako baseplate was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.See attached results.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that "during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size) (there was "rm/ll size 5" that was actually size 6 shape".Visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.An nc was raised to address this event.Product surveillance will continue to monitor for trends.
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Event Description
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It was reported that during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size).There was "rm/ll size 5" but it was actually size 6 shape.
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Manufacturer Narrative
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Reported event: an event regarding size/fit issue involving a mako baseplate was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.See attached results.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that "during a delivering mako instruments, our sales staff noticed a discrepancy of shape (size) (there was "rm/ll size 5" that was actually size 6 shape".Visual inspection of the returned device indicated that the device is in undamaged condition.Dimensional inspection performed on the device indicated the dimensions were out of specifications.Nc was raised to address this event.A classification letter from the fda has not been received; once the classification letter is received, a supplemental will be sent with the recall number.
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Search Alerts/Recalls
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