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Model Number N/A |
Device Problem
Component or Accessory Incompatibility (2897)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/10/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." this report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-01991 / 01992).
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Event Description
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During a procedure, the locking ring would not engage with the humeral bearing.Another set of implants was used to complete the procedure without significant delay.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.During the evaluation, damage was noted on the bearing, most likely attributed to attempts to manipulate the device with a hard instrument.A conclusive root cause of the event could not be determined, as damage to the mating component made recreation of the event impossible.
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Search Alerts/Recalls
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