WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 33680032 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 12/21/2023 |
Event Type
Injury
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Event Description
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The digital stryker prophecy team received a ct scan indicating that the patient underwent a a device explant surgery for reasons that are not available at the time of this report.
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Manufacturer Narrative
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The reported event could not be confirmed based on available medical record and medical expert assessment.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, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed "there is a girdle-stone situation visible in the respective ct scan.There is no further information available in this case, but an infection is likely the cause for the removal of the implant.The initial implantation was in august 2023, therefore the infection is after less than 6 months and therefore there is a little chance, that the infection occurred as a result of the implantation.Without any more information on the case this cannot be assessed with certainty." 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.According to the medical assessment performed by the hcp, it was identified that there is a girdle-stone situation visible in the ct scan and hence infection can be the likely cause for the removal of the implant, also there is a little chance that the infection occurred as a result of the implantation, but without any further information on the case this cannot be assessed with certainty.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition unknown.
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Manufacturer Narrative
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The reported event could not be confirmed based on available medical record and medical expert assessment.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, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed "there is a girdle-stone situation visible in the respective ct scan.There is no further information available in this case, but an infection is likely the cause for the removal of the implant.The initial implantation was in august 2023, therefore the infection is after less than 6 months and therefore there is a little chance, that the infection occurred as a result of the implantation.Without any more information on the case this cannot be assessed with certainty." 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.According to the medical assessment performed by the hcp, it was identified that there is a girdle-stone situation visible in the ct scan and hence infection can be the likely cause for the removal of the implant, also there is a little chance that the infection occurred as a result of the implantation, but without any further information on the case this cannot be assessed with certainty.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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The digital stryker prophecy team received a ct scan indicating that the patient underwent a a device explant surgery for reasons that are not available at the time of this report.
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Search Alerts/Recalls
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