Catalog Number UNK_WWA |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
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Patient Problem
Ossification (1428)
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Event Date 11/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.
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Event Description
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The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of the poly clean out the gutters and some heterotopic ossification.The poly is being removed to gain access and will then be replaced with the same size.
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Manufacturer Narrative
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The reported event could not be confirmed due to the lack of additional clinical information.A healthcare professional noted the following regarding the risks/complications of a heterotopic ossification: ¿in most of the cases the heterotopic ossifications do not produce any problems.Problems are mostly reported for the hip, sometimes for the shoulder.In the ankle soft tissue problems and other mechanical problems produce the vast majority of complications.¿ 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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The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of the poly clean out the gutters and some heterotopic ossification.The poly is being removed to gain access and will then be replaced with the same size.
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Search Alerts/Recalls
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