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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN SYNERGY FEMORAL STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P
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SMITH & NEPHEW, INC. UNKNOWN SYNERGY FEMORAL STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P Back to Search Results
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348)
Event Date 03/17/2017
Event Type  Injury  
Event Description
It was reported a revision surgery was performed after the patient stumbled and the neck of the stem broke causing pain.Stem and head were replaced during revision.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
UNKNOWN SYNERGY FEMORAL STEM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P
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
1450 brooks road
memphis, TN 38116
MDR Report Key6447293
MDR Text Key71297195
Report Number1020279-2017-00231
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeSF
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
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2017
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age54 YR
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