STRYKER GMBH SILICONE II MCP IMPLANT SIZE 50 (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER
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Model Number MCP-50 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Rheumatoid Arthritis (1724); Failure of Implant (1924)
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Event Date 10/25/2022 |
Event Type
Injury
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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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Event Description
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It was reported that a mcp silicone implant moved out of place.Had to re-implant new mcp-50.Patient has ra causing proximal plalanx to sublux/rotate, resulting in implant moving out of place.
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event, the patient activity levels as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the event description, the possible root cause could be linked to the patient's bone quality (presence of ra).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 a mcp silicone implant moved out of place.Had to re-implant new mcp-50.Patient has ra causing proximal plalanx to sublux/rotate, resulting in implant moving out of place.
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