• 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 UNKNOWN KNEE; PROSTHESIS, KNEE

  • 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 UNKNOWN KNEE; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Limited Mobility Of The Implanted Joint (2671); Fibrosis (3167)
Event Type  Injury  
Event Description
Information was received based on review of a journal article titled, "mortality and perioperative complications after unicompartmental knee arthroplasty".This study aimed to determine the 90-day incidence of perioperative complications and mortality of patients undergoing total knee arthroplasty.The oxford phase iii mobile bearing unicompartmental knee prosthesis and the vanguard m fixed bearing unicompartmental knee prosthesis were used, both manufactured at biomet.A patient was identified in the article that underwent partial knee arthroplasty on an unknown side and an unknown date.Subsequently, patient underwent manipulation under anesthesia due to inadequate range of motion and arthrofibrosis.There has been no further information provided and the patient outcome is unknown.
 
Manufacturer Narrative
The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This information was originally reported on 1825034-2015-02797 which referenced a journal article written on a study that this patient took part in.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN KNEE
Type of Device
PROSTHESIS, KNEE
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 Key4888839
MDR Text Key6019241
Report Number0001825034-2015-02798
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation Physician
Type of Report Initial
Report Date 06/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/25/2015
Initial Date FDA Received07/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
-
-