Model Number DWK503LA15 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Joint Laxity (4526)
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Event Date 03/17/2023 |
Event Type
Injury
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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It was reported that there was a patient underwent a total shoulder replacement.Due to increasing instability in joint over recent months, surgeon decided to convert the tsa to a reverse shoulder replacement.All components were well fixed.The glenoid poly implant had to be broken up in-situ and removed in pieces.The humeral component was extremely well fixed.Significant bone was attached to the central core/fins of the component.A reverse arthroplasty prosthesis was implanted.Stabile range of motion was demonstrated at the conclusion of surgery.
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Manufacturer Narrative
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Correction - g1.The reported event could not be confirmed since the device was not returned for evaluation.Photos were provided from the complaint reporter; however, the device was covered in biological material and a device inspection was not possible.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that there was a patient underwent a total shoulder replacement.Due to increasing instability in joint over recent months, surgeon decided to convert the tsa to a reverse shoulder replacement.All components were well fixed.The glenoid poly implant had to be broken up in-situ and removed in pieces.The humeral component was extremely well fixed.Significant bone was attached to the central core/fins of the component.A reverse arthroplasty prosthesis was implanted.Stabile range of motion was demonstrated at the conclusion of surgery.
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Search Alerts/Recalls
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