inforMED
OtherMBP

MIMIX

Received Sep 29, 2004 · Event occurred Sep 7, 2004

Report 1032347-2004-00019 · MDR key 547634

Device

Generic name

Bone Void Filler

Manufacturer

Biomet, Inc.

Model number

*

Catalog number

UNK

Lot number

UNK

Product problems

  • Explanted
  • Repair

Patient

*

  • Unspecified Infection
  • Surgical procedure
  • Impaired Healing
  • Treatment with medication(s)
  • Hospitalization required

Narrative

Description of Event or Problem

PT HAD A CALCIUM CEMENT BONE FILTER (POSSIBLY MIMIX) IMPLANTED AT AN EARLIER DATE (UNK) AND THE SKIN OVER THE IMPLANT WAS NOT HEALING AS INTENDED. PT WAS REFERRED TO DR WHO TREATED WITH ANTIBIOTICS FOR MRSA INFECTION. AFTER TREATMENT, DR NOTICED SOME NEW SKIN GROWTH, BUT DECIDED A FLAP WAS NEEDED. WHEN DR PERFORMED THE REVISION SURGERY, HE OBSERVED THREE LAYERS OF THE IMPLANT, WITH TITANIUM MESH BETWEEN TWO OF THE LAYERS AND SOME STAINLESS STEEL WIRE. DR REMOVED SOME OF THE IMPLANT, INCLUDING THE MOST SUPERFICIAL LAYER, BURRED DOWN THE REST TO BE SMOOTH, AND COVERED WITH A FLAP. DEFECT WAS 2-3" X 3-4" IN SIZE.