inforMED
InjuryHSH

UNKNOWN_RECONSTRUCTIVE_PRODUCT

Received Oct 15, 2014 · Event occurred Sep 22, 2014

Report 0002249697-2014-03896 · MDR key 4175382

Device

Generic name

Implant

Catalog number

UNK_REC

Lot number

UNKNOWN

Product problems

  • Device Slipped

Patient

58 YR

  • Pain

Narrative

Description of Event or Problem

IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT KNEE DUE TO PAIN, AND A LOOSE FEMORAL COMPONENT.

Additional Manufacturer Narrative

THE CATALOG NUMBER AND LOT CODE WERE NOT REPORTED. THE DEVICE WAS REPORTED AS AN UNKNOWN SIZE 4 CR FEMUR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE IS NOT AVAILABLE.