STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN MDM LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number UNK_SHC |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 12/18/2023 |
Event Type
Injury
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Event Description
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Patient had multiple hip dislocations and is in need of a revision.Dr requested to exchange the mdm liner and lengthen the neck.Surgery was performed without incident.
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.H3 other text : device not returned to the manufacturer.
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Event Description
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Patient had multiple hip dislocations and is in need of a revision.Dr requested to exchange the mdm liner and lengthen the neck.Surgery was performed without incident.Update: "revised the liner and head only.Stem remained implanted.".
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Manufacturer Narrative
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Reported event: an event regarding dislocation involving an unknown liner was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to recurrent dislocations.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Correction: date of birth (a2) entered in initial report was error.
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