STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number 502-03-52D |
Device Problems
Degraded (1153); Loss of Osseointegration (2408)
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Patient Problems
Foreign Body Reaction (1868); Inadequate Osseointegration (2646)
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Event Date 10/05/2022 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that the patient's right hip was revised due to shell loosening.Intra-operatively, black tissue was noted in the patient's joint.A shell, 2 screws, liner and head were revised.Rep confirmed there are no allegations against the revised liner.
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Manufacturer Narrative
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Reported event: an event regarding loosening and wear/metallosis involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that the device was recently explanted.Blood, tissue, and bone residue are visible on the bone-interfacing surfaces of the device.Nothing further remarkable is observed.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 shell loosening and intraoperatively black tissue was observed in the hip joint.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that the device was recently explanted.Blood, tissue, and bone residue are visible on the bone-interfacing surfaces of the device.Nothing further remarkable is observed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as 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.
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Event Description
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It was reported that the patient's right hip was revised due to shell loosening.Intra-operatively, black tissue was noted in the patient's joint.A shell, 2 screws, liner and head were revised.Rep confirmed there are no allegations against the revised liner.
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Search Alerts/Recalls
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