STRYKER GMBH 20 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER
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Model Number PIP-20 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2022 |
Event Type
Injury
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Event Description
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It was reported that the "patient dislocated." the patient underwent a revision surgery.
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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.
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Manufacturer Narrative
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Please note correction to h6 clinical signs code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided 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.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.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 the "patient dislocated." the patient underwent a revision surgery.
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Search Alerts/Recalls
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