FDA Adverse Event Injury Summary report: N

BIOMET HYBRID GLENOID BASE

MDR report key: 2211570 · Received March 7, 2008

Report

Report Number
2211570
Event Type
Injury
Date Received
March 7, 2008
Date of Event
February 12, 2008
Report Date
February 20, 2008
Manufacturer
BIOMET ORTHOPEDICS, INC.
Product Code
KWS
Product Problem
Yes
Report Source
User Facility report
Reporter Location
NY, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

A (B)(6) YEAR-OLD MALE UNDERWENT LEFT SHOULDER ARTHROPLASTY ON (B)(6) 2008. INTRA-OPERATIVELY, THE GLENOID BONE WAS REAMED AND PREPARED FOR THE BIOMET GLENOID BASE IMPLANT. THE TRIAL FIT, CONFIRMED BY THE BIOMET REP, (B)(6). PRIOR TO SCREWING THE CENTRAL PEG INTO THE ACTUAL IMPLANT, PLACEMENT OF THE IMPLANT (HYBRID GLENOID BASE, 4 MM MEDIUM) WAS ATTEMPTED. HOWEVER, THE IMPLANT SAT PROUD, WHICH WAS DIFFERENT FROM HOW THE TRIAL SAT, ACCORDING TO THE SURGEON. THE SURGEON RE-REAMED, RE-DRILLED THE NECESSARY HOLES, AND AGAIN THE TRIAL SEATED APPROPRIATELY. IMPLANTATION WAS ATTEMPTED WITH A SECOND HYBRID GLENOID BASE (4 MM MEDIUM), WHICH, AS WITH THE FIRST ONE ATTEMPTED, ALSO SAT PROUD. MR. (B)(6) CONFIRMED THE WAY THE IMPLANT SAT VERSUS THE TRIAL. THE SURGEON DID NOT USE EITHER OF THE BIOMET HYBRID GLENOID BASES, AND INSTEAD IMPLANTED A BIOMET BIOMODULAR KEELED GLENOID (USED SAME REAMER). THE BIOMODULAR TRIAL FIT AND THE BIOMODULAR IMPLANT SEATED APPROPRIATELY, AND WAS CEMENTED. THE PROCEDURE WAS WELL-TOLERATED BY THE PT, WHO WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE SURGEON SPOKE VIA TELEPHONE WITH BIOMET ENGINEER (B)(6). THIS REPORT IS THE SECOND OF THE TWO BIOMET GLENOID BASES ATTEMPTED. A SEPARATE 3500A FORM IS SUBMITTED FOR THE FIRST BIOMET GLENOID BASE ATTEMPTED IN SAME CASE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BIOMET HYBRID GLENOID BASE MOLDED POLYETHYLENE HYBRID GLENOID BASE KWS BIOMET ORTHOPEDICS, INC. REF 113954 090500

Patients

Seq Age Sex Outcome Treatment
1 65 YR Required Intervention