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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSSUR AMERICAS TOTAL KNEE 2100; PROSTHETIC KNEE
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OSSUR AMERICAS TOTAL KNEE 2100; PROSTHETIC KNEE Back to Search Results
Model Number 2100
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Initially the manufacturer was informed that the prosthetic knee was buckling and the patient might have fallen but no information were given regarding any injuries.After several attempts contacting the clinic the manufacturer was informed that the patient had been injured and had to be hospitalized.The device has not been returned for analysis.
 
Event Description
Prosthetic knee was buckling and the patient was hospitalized.
 
Event Description
User fell when using his prosthetic knee.User experienced serious injuries as he injured his hip and needed to undergo a surgery.
 
Manufacturer Narrative
Initially the manufacturer was informed that the prosthetic knee was buckling and the patient might have fallen but no information were given regarding any injuries.After several attempts contacting the clinic the manufacturer was informed that the patient had been injured and had to be hospitalized.
 
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Brand Name
TOTAL KNEE 2100
Type of Device
PROSTHETIC KNEE
Manufacturer (Section D)
OSSUR AMERICAS
910 burstein dr.
albion MI 49224
MDR Report Key10655463
MDR Text Key210611156
Report Number0001836248-2020-00003
Device Sequence Number1
Product Code ISY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number2100
Was Device Available for Evaluation? No
Date Manufacturer Received09/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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