ENCORE MEDICAL L.P EMPOWR PARTIAL KNEE; EMPOWR PARTIAL KNEETM, TIBIAL INSERT, SIZE 6, 8MM
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Model Number 347-08-706 |
Device Problem
Fitting Problem (2183)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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Event Description
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Complaint - surgeon went to put in the insert but it wasn't seated completely in the baseplate.Hospital discarded insert.
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Manufacturer Narrative
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Manufacturer narrative: the reason for this complaint was reported as misalignment.This event occurred during surgery near the patient.There was another suitable device available, the incident did cause a 3 min.Delay in surgery, however, surgery was completed as intended, there was no risk or adverse event reported and the item was inspected prior to surgery and was found to be acceptable.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported device, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.Complaint database review showed no previous complaints against this device.This event is possibly attributable to misalignment which surgical devices are subjected to.Surgical items condition can be determined while being used for its intended purpose.The replacement of surgical items does not indicate a product deficiency, failure or issue.This is not an event associated with a product failure, malfunction or issue.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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Manufacturer Narrative
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Manufacturer narrative: the reason for this complaint was reported as surgeon went to put in the insert but it wasn't seated completely in the baseplate.Surgeon was attempting to impact the final poly implant into the tibial baseplate but couldn't get the anterior aspect to fully seat/lock.It was good on the posterior side.Surgeon pulled out another poly which seated/locked fine.This event occurred during surgery near the patient.There was another suitable device available, the incident did cause a 3 minute delay in surgery, however, surgery was completed as intended, there was no risk or adverse event reported and the item was inspected prior to surgery and was found to be acceptable.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported device, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.Complaint database review showed no previous complaints against this device.This event is possibly attributable to misalignment which surgical devices are subjected to.Surgical items condition can be determined while being used for its intended purpose.The replacement of surgical items does not indicate a product deficiency, failure or issue.This is not an event associated with a product failure, malfunction or issue.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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Event Description
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Complaint/primary surgery - surgeon went to put in the insert but it wasn't seated completely in the baseplate.Hospital discarded a more detailed description from agent: surgeon was attempting to impact the final poly implant into the tibial baseplate but couldn't get the anterior aspect to fully seat/lock.It was good on the posterior side.Surgeon pulled out another poly which seated/locked fine.
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Search Alerts/Recalls
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