Catalog Number 625-0T-32E |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544)
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Event Date 06/23/2014 |
Event Type
Injury
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Event Description
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It was reported that, "i¿m (b)(6), and i had a total hip replacement in (b)(6) 2012.Surgeon implanted an abg ii hip device.I send you the characteristics of the implanted devices and my x-rays, because i still have pain and difficulties when i walk.I would like to know if my hip device is the model recalled by stryker.".
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Manufacturer Narrative
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Additional devices listed in this report: cat 4845-0204, abg ii no4 cementless left v40 1, lot code g3175979d.Cat 6565-0-132, alumina v40-femoral head 33mm +0mm nk, lot code 40628702.Cat 542-11-50e, trident psl ha cluster 50mm, lot code, 40919401.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report.Devices implanted.
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Event Description
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It was reported that, "i¿m an (b)(6) lady, (b)(6) years old, and i had a total hip replacement in (b)(6) 2012.Surgeon implanted an abg ii hip device.I send you the characteristics of the implanted devices and my x-rays, because i still have pain and difficulties when i walk.I would like to know if my hip device is the model recalled by stryker.".
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Manufacturer Narrative
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An event regarding pain and difficulty walking involving a trident alumina insert was reported.The event was not confirmed.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: ¿cause of the problem may be related to cup malposition in low inclination which would be a procedure-related factor but the amount of information is not enough to establish such a root cause of failure with enough certainty due to lack of appropriate further information.¿ device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: a complaint history review confirmed no other similar events for the reported lot.Conclusions: the reported device is not part of a recall.The exact cause of the event could not be determined because of a lack of information.While x-rays suggest that the problem may have been related to cup malposition, there is not enough information to establish such a root cause of failure.Further information such as the reported device, patient medical records, and additional x-rays are needed to complete the investigation for determining the root cause.
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Search Alerts/Recalls
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