ENCORE MEDICAL, L.P. SLIDING CORE, UHMPWE,6M (STERILE PACKAGED); PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
|
Back to Search Results |
|
Model Number 400-140F |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
Event Date 11/16/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
|
|
Event Description
|
As reported: "infection after prior revision surgery.Poly removed.Staged infection control.Reinserted new poly today.".
|
|
Event Description
|
As reported: "infection after prior revision surgery.Poly removed.Staged infection control.Reinserted new poly today.".
|
|
Manufacturer Narrative
|
Please note corrections in d3 manufacturer entity, the fda registration number for encore medical, l.P.Is (b)(4) the reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event such as the infection form filled by the customer 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 more information is provided, the case will be reassessed.
|
|
Search Alerts/Recalls
|
|
|