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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 40OD 22ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 40OD 22ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Catalog Number 71324040
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Information (3190)
Event Date 10/20/2016
Event Type  Injury  
Event Description
It was reported to us that patient had dislocated the hip 6 weeks post hemiarthroplasty with implant being removed and not revised.
 
Manufacturer Narrative
3 devices have been received but only one is able to be identified at the moment.(b)(4).
 
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Brand Name
TANDEM INTL BIPOLAR 40OD 22ID
Type of Device
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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 odoy
schachenallee 29
aarau 5001
SZ   5001
0628320660
MDR Report Key6095615
MDR Text Key59761487
Report Number1020279-2016-00871
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K023743
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number71324040
Device Lot Number13CM15033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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