Model Number N/A |
Device Problems
Failure to Osseointegrate (1863); Osseointegration Problem (3003)
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Patient Problems
Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
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Event Date 09/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) g2 - literature: tanaka ks, andaya vr, thorpe sw, et al.Survival and failure modes of the compress® spindle and expandable distal femur endoprosthesis among pediatric patients: a multi-institutional study. j surg oncol.2023;127(1):148-158.Doi:10.1002/jso.27094 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01565.0001825034-2023-01566.
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Event Description
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A journal article was retrieved from journal of surgical oncology (2022) that reported a study from the west coast of the united states.The purpose of the retrospective cohort study was to report the outcome of pediatric patients with a primary bone sarcoma at the distal femur reconstructed with a compress/oss distal femur expandable endoprosthesis and to determine the survivorship of the cps spindle, modes of failure using the international society of limb salvage (isols) classification and the rate of and risks associated with prosthetic joint infections.The study reviewed 36 patients who underwent surgery between a 20-year timeframe at 5 study centers.All patients were treated for primary oncologic diagnoses of osteosarcoma (34) or ewing sarcoma (2).The study population had a mean age of 10.7 years at time of surgery and range of 5 to 15 years old; 24 males/12 females.Follow-up was conducted for a minimum of 2 years (range: 10-246 months).The study reported one patient received an undersized centering sleeve that caused angulation of the endoprosthesis resulting in a femoral fracture that was corrected by removal of the original spindle and revision to a new spindle apparatus proximal to the fracture.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Event Description
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It was further reported that the femoral fractured occurred post op.The surgeon likely thought they were putting in the correct size but when the looking at the x-rays post op, it was thought that the centering sleeve was a little bit small which may have contributed to the fracture.It was reported that no further information is available.
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Manufacturer Narrative
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An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01565.0001825034-2023-01566.0001825034-2023-01910.
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Search Alerts/Recalls
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