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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 11 STEM PRIMARY HO PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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SMITH & NEPHEW, INC. EMP 11 STEM PRIMARY HO PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number 71291102
Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)
Event Date 02/22/2017
Event Type  Injury  
Manufacturer Narrative
Implant date: is approximation as only the year is known. Udi: (b)(4).
 
Event Description
It was reported that patient underwent a revision surgery due to femoral stem fracture. It was reported that patient was apparently lifting something heavy, didn¿t fall but the stem fractured. There aren't any evidence of any periprosthetic fractures. The stem was difficult to remove.
 
Event Description
Femoral stem, sleve, head, and acetabular insert have been revised.
 
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Brand NameEMP 11 STEM PRIMARY HO
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
claudia de santis
schachenallee 29
aarau 5001
SZ   5001
0628320660
MDR Report Key6383315
MDR Text Key69205246
Report Number1020279-2017-00158
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K042127
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71291102
Device Lot Number09KM14223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2017
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

Patient Treatment Data
Date Received: 03/07/2017 Patient Sequence Number: 1
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