Model Number 2030-6540-1 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 10/26/2022 |
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
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Event Description
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It was reported by the sales rep that the surgeon notify on a possible removal case due to loosening.
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Event Description
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It was reported by the sales rep that the surgeon notify on a possible removal case due to loosening.Update via clinician review: [.Preoperative x-rays reveal a cementless acetabular cup with adequate fixation and possible polyethylene wear.The femoral component showed significant osteolysis with probable pathological fracture of the greater trochanter with very little cement fixation in a distal pedestal beneath the femoral implant [.].
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Manufacturer Narrative
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Correction: investigation conclusion reveals that this reported device is not a suspected cause or contributor to the patient's experience and considered concomitant.The aer decision has been updated accordingly.An event regarding osteolysis, loosening, pathological fracture of a stem involving an other hip screw was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.A clinical review of the provided medical information indicated [.] there is a cementless acetabular component in place.Position and fixation appear satisfactory [.] a full complaint investigation is completed for the stem and liner within the same pi.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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Search Alerts/Recalls
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