Model Number DWJ530 |
Device Problems
Off-Label Use (1494); Osseointegration Problem (3003)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 04/17/2023 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device retained by hospital.
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Event Description
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There was an early revision of a perform reversed glenoid implanted.Fluids and tissues have been harvested during the revision case for a suspected infection.There is no results of the pathology tests.Once the reverse glenoid was removed, the surgeon packed the glenoid vault with some femoral head graft and has converted the stem to a hemi prosthesis.The stem was not revised.
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Event Description
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There was an early revision of a perform reversed glenoid implanted.Fluids and tissues have been harvested during the revision case for a suspected infection.There is no results of the pathology tests.Once the reverse glenoid was removed, the surgeon packed the glenoid vault with some femoral head graft and has converted the stem to a hemi prosthesis.The stem was not revised.
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Manufacturer Narrative
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Please note the corrections made to the h6 (results & conclusion code): the reported event was confirmed through the evaluation of a medical expert.Based on the above investigation and provided information, the root cause was attributed to user related issue as well as a patient related issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The medical opinion of a medical expert was requested to evaluate the risk of this event: ¿on the x-ray i can confirm the event of loosening of the glenoid base plate.The use of the perform reversed augmented glenoid implant with the djo humeral stem is off label.The large functional neck shaft-angle due to placement of the humeral stem has led to notching and bone loss.The fact that no screws are broken shows that insufficient bone support is the most likely reason for this event of glenoid component loosening.There is no information regarding the possibility of infection.To me this is a combination of user- and patient-related factors leading to this event.» if the device is returned or if any additional information is provided, the investigation will be reassessed.
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Search Alerts/Recalls
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