TORNIER S.A.S. UNKNOWN TORNIER FLEX INSERT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Catalog Number UNK_WTM |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
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Patient Problems
Stroke/CVA (1770); Inadequate Osseointegration (2646)
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Event Date 06/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.
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Event Description
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On (b)(6) 2023, a revision surgery took place, utilizing the blueprint planning feature.Subsequent to the surgery, a stroke occurred in the patient.It is postulated that the patient's arm underwent pulling forces by hospital staff during transfers, resulting in complications.Consequently, both the baseplate and sphere became dislodged from their intended positions.In response to this incident, the decision was made to extract and replace the baseplate, screws, and sphere (perform reversed).The original ascend flex stem remained in situ, while the tray and poly (tornier flex) were substituted.Notably, no x-rays were taken; rather, a blueprint ct scan was employed.No exceptional circumstances, such as additional trauma, underlying medical conditions, or issues like delayed or non-union, were identified in relation to the aforementioned event.
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Manufacturer Narrative
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Please note the corrections made to the h6 device code, results code, d3 manufacturer entity and the b5 executive summary: the reported event was confirmed through the evaluation of a medical expert.Since data was provided, the opinion of a medical expert was sought and stated as follows: «yes, i belief pulling the patients arm may have been a contributing factor in this event, especially if it involved the paralytic arm, where the muscles would not be able to guard the joint.The blueprint images show from the glenoid bone imprint of the baseplate, that the baseplate was atypically positioned relatively superiorly and posteriorly, possibly making the initial fixation less optimal.» 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 was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.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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A revision surgery took place, utilizing the blueprint planning feature.Subsequent to the surgery, a stroke occurred in the patient.It is postulated that the patient's arm underwent pulling forces by hospital staff during transfers, resulting in complications.Consequently, both the baseplate and sphere became dislodged from their intended positions.In response to this incident, the decision was made to extract and replace the baseplate, screws, and sphere (perform reversed).The original ascend flex stem remained in situ, while the tray and poly (tornier flex) were substituted.
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