STRYKER SUZHIOU 26MM -3MM V40 TRIAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 6264-8-026 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/02/2018 |
Event Type
malfunction
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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.
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Event Description
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After leaving the hospital, it was reported that the v40 head trial remained in the patient.It is believed that credibility is high because x - ray does not have such shadows and instrument points.Due to the risk of fracture at the time of intraoperative, cup trial was not worn, temporary reduction with rasp, neck, head trial.The implant also entered successfully, so it seems that the trial head is in the joint capsule.Events and considerations occurred because it was not confirmed that the trial head was removed at trial and that the instruments was not returned to the instrument table.
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Event Description
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After leaving the hospital, it was reported that the v40 head trial remained in the patient.It is believed that credibility is high because x - ray does not have such shadows and instrument points.Due to the risk of fracture at the time of intraoperative, cup trial was not worn, temporary reduction with rasp, neck, head trial.The implant also entered successfully, so it seems that the trial head is in the joint capsule.Events and considerations occurred because it was not confirmed that the trial head was removed at trial and that the instruments was not returned to the instrument table.
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Manufacturer Narrative
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An event regarding off label use involving a partnership trial head was reported.It was identified that a partnership trial head was left implanted during surgery.Conclusion: based on the provided information it has been determined that this event is associated with an off-label application.A review of ifu qin (b)(4) revision ab, noted the following: utilization howmedica osteonics trial components should be used for size determination, preparation evaluation, trial reduction and range of motion evaluation, thus helping to preserve the integrity of the actual implants and their sterile packaging.A review of the trident acetabular system psl surgical protocol, triden-sp-3_rev-2_14606, noted the following: step 8: head assembly prior to head assembly, neck length selection may be re-evaluated using a stryker v40 or c-taper trial head.Place the trial head onto the stem neck taper and reduce the hip to verify that the mechanics have not been altered due to implant seating.Remove the trial head and dry the implant trunnion with a laparotomy sponge or sterile towel.Select the appropriate corresponding v40 or c-taper femoral head size and place it onto the dry trunnion of the femoral stem with a slight twist.Impact the head with two moderate blows using the stem head impactor ((b)(4)).No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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