STRYKER GMBH 20 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER
|
Back to Search Results |
|
Model Number PIP-20 |
Device Problem
Break (1069)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 03/16/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
|
|
Event Description
|
It was reported the silicone pip implant was broken, resulting in revision surgery.
|
|
Manufacturer Narrative
|
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 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 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 any further information is provided, the complaint report will be updated.
|
|
Event Description
|
It was reported the silicone pip implant was broken, resulting in revision surgery.
|
|
Search Alerts/Recalls
|
|
|