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

MAUDE Adverse Event Report: BIOMET, INC. BIOMET OSS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

  • 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, INC. BIOMET OSS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem Failure of Implant (1924)
Event Date 01/03/2019
Event Type  Injury  
Event Description
The biomet oss hip implant used in my 2016 hip replacement snapped in half on (b)(6) 2019, requiring an emergency hip replacement on (b)(6) 2019. I was sitting on my sofa when the break occurred. I have all my medical records. You are welcome to review. The implant failed. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIOMET OSS
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
BIOMET, INC.
MDR Report Key11760529
MDR Text Key249000819
Report NumberMW5101118
Device Sequence Number1
Product Code JDL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/30/2021 Patient Sequence Number: 1
-
-