RINGLOC FULL HEMI SLD/APX SHELL
Received Nov 20, 2002 · Event occurred Oct 17, 2002
Report 1825034-2002-00138 · MDR key 429001
Device
Generic name
Prosthesis, Hip, Comp.
Manufacturer
Biomet, Inc.Model number
NACatalog number
14-104052
Lot number
583330
Product problems
- Device remains implanted
Patient
Not reported
- Post Operative Wound Infection
- Hospitalization required
Narrative
Description of Event or Problem
REPORT RECEIVED FROM HOSPITAL STATING THAT DURING THE TIME PERIOD FROM EVENT DATE TO 11/2002, ELEVEN TOTAL JOINT AND/OR REVISION PROCEDURES WERE PERFORMED, WITH FIVE OF THESE CASES RESULTING IN POST OPERATIVE INFECTION. THE PROCEDURES PERFORMED ARE COMPRISED OF VARIOUS COMPONENTS BEING IMPLANTED. THE COMPANY HAS NO INFO THAT THESE INCIDENTS OF INFECTION ARE IN ANY WAY RELATED TO THE BIOMET DEVICE. THE COMPANY IS CONTINUING TO GATHER FURTHER INFO, BUT TO DATE THERE IS NO COMMON THREAD INVOLVING THE DEVICE OR ITS COMPONENTS THAT WOULD LEAD BIOMET TO CONCLUDE THAT THE DEVICE CAUSED ANY INFECTION. INVESTIGATION CONTINUES AT THE HOSPITAL FOR NON-DEVICE RELATED CAUSES. RIGHT "THA" PERFORMED IN 2002, RESULTING IN POST-OPERATIVE INFECTION.