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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) MODULAR FEMORAL NECK; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. PROFEMUR(R) MODULAR FEMORAL NECK; HIP COMPONENT Back to Search Results
Catalog Number PHA0-1254
Device Problems Loose or Intermittent Connection (1371); Noise, Audible (3273)
Patient Problems Unspecified Infection (1930); Pain (1994); Reaction (2414)
Event Date 12/01/2015
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly the patient was revised due to following complications: pain, infection, loosening, popping, crunching, noises and metallosis (right).
 
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Brand Name
PROFEMUR(R) MODULAR FEMORAL NECK
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
9018674771
MDR Report Key6114421
MDR Text Key60387133
Report Number3010536692-2016-01426
Device Sequence Number1
Product Code LWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberPHA0-1254
Device Lot Number079890997
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date11/14/2016
Date Manufacturer Received11/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
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