• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP PRIMARY STEM 8MM MINI; PROSTHESIS, SHOULDER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET ORTHOPEDICS COMP PRIMARY STEM 8MM MINI; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 05/27/2015
Event Type  Injury  
Event Description
It was reported that patient underwent right total shoulder arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to deep joint infection.Surgeon suspected that patient had been infected since initial procedure, and that is likely why there was no ingrowth into porous peg.All components were removed and replaced with cement spacers.
 
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.There are warnings in the package insert that state that this type of event can occur: "early or late postoperative infection and allergic reaction." this report is number 1 of 6 mdrs filed for the same event (reference 1825034-2015-02484 & 02485 & 02486 & 02487 & 02488 & 02489).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COMP PRIMARY STEM 8MM MINI
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key4827760
MDR Text Key15838361
Report Number0001825034-2015-02484
Device Sequence Number1
Product Code MBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK060692
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date02/29/2024
Device Model NumberN/A
Device Catalogue Number113628
Device Lot Number175320
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/27/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-