Model Number 5450-35-500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Scar Tissue (2060)
|
Event Date 08/06/2009 |
Event Type
Injury
|
Event Description
|
Pc was created to capture the event.(pg 2560) (b)(6) 2009 operative records indicate the patient received a left total hip revision due to significant scarring and gross infection.Acetabular cage and prostalac was removed and irrigation and debridement was performed.Doi: (b)(6) 2009.Dor: (b)(6) 2009.Left hip.
|
|
Manufacturer Narrative
|
Product complaint #: (b)(4).Initial reporter occupation: lawyer.Dmf# 13704.Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Search Alerts/Recalls
|