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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 12 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P

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SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 12 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P Back to Search Results
Catalog Number 71309012
Device Problems Loose or Intermittent Connection (1371); Osseointegration Problem (3003); Unintended Movement (3026)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 08/12/2016
Event Type  Injury  
Manufacturer Narrative
[(b)(4)].
 
Event Description
Only femoral stem and femoral head were revised during the revision surgery, due to subsidence of the stem.
 
Manufacturer Narrative
The associated complaint devices were not returned. A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. A review of complaint history on the listed parts revealed no additional complaints for the listed batches. Without the actual product involved, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened. No further actions are being taken at this time. We consider this investigation closed.
 
Event Description
It was reported that right hip revision surgery was performed due to groin pain, aseptic loosening, need for open reduction and internal fixation of femur.
 
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Brand NameSYN POR PLUS HA SO STEM SZ 12
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
spa park
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
spa park
memphis TN 38116
Manufacturer Contact
markus poettker
schachenallee 29
aarau 05001
SZ   05001
MDR Report Key6885725
MDR Text Key107022364
Report Number3005975929-2017-00314
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K002996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 05/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71309012
Device Lot Number16CM10120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/14/2016
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: 09/22/2017 Patient Sequence Number: 1
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