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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. WRIGHT ACETABULAR CUP; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. WRIGHT ACETABULAR CUP; HIP COMPONENT Back to Search Results
Device Problems Fracture (1260); Failure to Align (2522); Device Dislodged or Dislocated (2923)
Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374)
Event Date 07/10/2013
Event Type  Injury  
Event Description
Allegedly the patient was revised due to aseptic loosening stem; dissociation of liner; implant fracture head; implant fracture stem; malalignment stem; periprosthetic fracture stem (left).(b)(4).
 
Manufacturer Narrative
This is the same event as 3010536692-2015-00352, -00353.This report will be updated when investigation is complete.Trends will be evaluated.This event occurred in (b)(6).
 
Manufacturer Narrative
The complaint database was reviewed and analysis showed no trend for item/lot.
 
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Brand Name
WRIGHT ACETABULAR CUP
Type of Device
HIP COMPONENT
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 Key4508421
MDR Text Key5443626
Report Number3010536692-2015-00351
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date07/10/2013
Event Location Hospital
Date Manufacturer Received04/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
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