inforMED
InjuryHTG

UNKNOWN DEPUY PATELLA

Received Feb 6, 2012 · Event occurred Jan 9, 2012

Report 1818910-2012-03147 · MDR key 2440020

Device

Generic name

Patella Prosthesis

Manufacturer

Depuy Warsaw

Catalog number

ASKU

Lot number

ASKU

Product problems

  • Insufficient Device Problem Information

Patient

43 YR

  • Unspecified Infection
  • Osteolysis

Narrative

Description of Event or Problem

PATIENT WAS REVISED TO ADDRESS POSSIBLE INFECTION. MINIMAL OSTEOLYSIS WAS ALSO REPORTED.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN DETERMINED TO BE A DUPLICATION OF AN EARLIER REPORT, 1818910-2012-02816. THEREFORE, THIS REPORT IS BEING CLOSED.

Additional Manufacturer Narrative

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Remedial action

  • Other