MAKO SURGICAL CORP. UNKNOWN_RESTORIS MCK MEDIAL UKA; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number UNK_OFL |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Insufficient Information (4580)
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Event Date 01/01/2013 |
Event Type
Injury
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Manufacturer Narrative
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As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.Device not returned.
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Event Description
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This pi is for the 2013 arthroscopy of the patient's left knee.As reported: "this principal investigator performed initial surgery and followed up with patient post-operatively.Information collected on patient reported: arthroscopy (2013) - patient experiencing pain, patellofemoral joint replacement (2014), arthroscopy (2014) - patient experiencing pain, locking, and giving way" patient had a restoris mck medial construct in situ at the time of event.
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Manufacturer Narrative
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Update to product code, common device name and g4.Reported event: an event regarding involving pain was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -clinician review: no medical records were received for review with a clinical consultant -device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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Event Description
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This pi is for the 2013 arthroscopy of the patient's left knee.As reported: "this principal investigator performed initial surgery and followed up with patient post-operatively.Information collected on patient reported: arthroscopy (2013) - patient experiencing pain, patellofemoral joint replacement (2014), arthroscopy (2014) - patient experiencing pain, locking, and giving way" patient had a restoris mck medial construct in situ at the time of event.
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Search Alerts/Recalls
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