TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE 10 DG TILTED 36MM X 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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Catalog Number DWD181 |
Device Problem
Unstable (1667)
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Patient Problems
Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526)
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Event Date 03/13/2024 |
Event Type
Injury
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Event Description
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As reported: "primary reverse shoulder arthroplasty, (b)(6) 2023.Patient complained of occasional instability, discomfort on movement, of this shoulder joint, over many months.Surgeon concluded, due to patient undergoing multiple operations on this shoulder, including cuff repair, that the patient has a soft tissue envelop instability.Decision made by surgeon to increase glenosphere size, and implant a more constrained poly liner.This was performed, and range of motion on reduction was acceptable, and joint found to be stable.All other primary implants left insitu.Hence, only 3 x prosthesis exchanged - reverse tray, poly insert and glenosphere.Shoulder joint stable at conclusion of procedure.".
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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.Should additional information become available, it will be provided in a supplemental report.
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Manufacturer Narrative
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The reported event could be confirmed, bases on the evaluation done by hcp on provided x-ray images.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, design & manufacturing related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.However, on the available x-rays medical opinion was sought from an experienced independent medical expert as below, ¿the images show an inferior subluxation of the humerus in relation to the glenosphere.This is indeed a sign of insufficient soft tissue tension and joint instability.Other than that, all implant components are intact and the humeral stem and glenoid baseplate are well-fixated to the bone¿ based on investigation, the root cause was attributed to a patient related issue.The failure was caused due to insufficient soft tissue tension.If device is returned or any further information is provided, the investigation report will be reassessed.
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Event Description
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As reported: "primary reverse shoulder arthroplasty, (b)(6) 2023.Patient complained of occasional instability, discomfort on movement, of this shoulder joint, over many months.Surgeon concluded, due to patient undergoing multiple operations on this shoulder, including cuff repair, that the patient has a soft tissue envelop instability.Decision made by surgeon to increase glenosphere size, and implant a more constrained poly liner.This was performed, and range of motion on reduction was acceptable, and joint found to be stable.All other primary implants left insitu.Hence, only 3 x prosthesis exchanged - reverse tray, poly insert and glenosphere.Shoulder joint stable at conclusion of procedure.".
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