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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DURAMER(R) SLR BIPOLAR ACETABULAR SHELL LINER; HIP COMPONENT, CODE:KWY
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MICROPORT ORTHOPEDICS INC. DURAMER(R) SLR BIPOLAR ACETABULAR SHELL LINER; HIP COMPONENT, CODE:KWY Back to Search Results
Catalog Number 1700-2808
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/30/2013
Event Type  Injury  
Manufacturer Narrative
The complaint database was reviewed and analysis showed no trend for item/lot.
 
Event Description
Allegedly disengaged within one month of implantation.
 
Manufacturer Narrative
The investigation is not complete.Trends will be evaluated.This report will be updated when the investigation is complete.This event occurred in (b)(6).This is the same event as 3010536692-2014-00045, 00047.
 
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Brand Name
DURAMER(R) SLR BIPOLAR ACETABULAR SHELL LINER
Type of Device
HIP COMPONENT, CODE:KWY
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
901867-441
MDR Report Key3595852
MDR Text Key17551199
Report Number3010536692-2014-00046
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number1700-2808
Device Lot Number1490018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2014
Is the Reporter a Health Professional? No
Distributor Facility Aware Date12/30/2013
Event Location Hospital
Date Manufacturer Received03/19/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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