Catalog Number 4900-1-111 |
Device Problems
Dent in Material (2526); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/10/2015 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.
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Event Description
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The pharmacist at the hospital returned the device to stryker (b)(4) without any mention.After a phone call to the contact person, she reported that "the stem was returned because it had like an impact on it.The surgeon did not want to use it.Another stem was available for complete the procedure without delay or adverse consequences.".
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Manufacturer Narrative
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An event regarding damage involving a dedicace stem was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection for the stem noted residue at the distal end of the stem.There was no evidence of damage or an 'impact' to the device.Material analysis report concluded that: the indication observed was a white residue with evidence of both poly(methyl-methacrylate) and zirconium.Both of which are known ingredients in bone cement used for fixation of a prosthesis to living bone in orthopaedic.Medical records received and evaluation: not performed as no medical records were provided.Device history review: the device was 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: the exact cause of the event could not be determined based on the information provided.In the event it is stated that there was an 'impact' noted on the device.The was no evidence of damage on the returned device, however a reside was noted on the distal end of the stem.Material analysis concluded that: the indication observed was a white residue with evidence of both poly(methyl-methacrylate) and zirconium.Both of which are known ingredients in bone cement used for fixation of a prosthesis to living bone in orthopaedic.The dedicace stem is indicated for cemented hip applications.The supplier of the stem confirmed that there is no bone cement or similar products used in lmo.No further investigation is possible at this time.If additional information becomes available, this investigation will be reopened.
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Event Description
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The pharmacist at the hospital returned the device to stryker (b)(4) without any mention.After a phone call to the contact person, she reported that "the stem was returned because it had like an impact on it.The surgeon did not want to use it.Another stem was available for complete the procedure without delay or adverse consequences.".
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Search Alerts/Recalls
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