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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA HO STEM SZ 14 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCMNTD, METAL/POLYMER, NON-POROUS, C-P

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SMITH & NEPHEW, INC. SYN POR PLUS HA HO STEM SZ 14 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCMNTD, METAL/POLYMER, NON-POROUS, C-P Back to Search Results
Catalog Number 71309114
Device Problem Unintended Movement (3026)
Patient Problems Bone Fracture(s) (1870); Injury (2348)
Event Date 09/06/2017
Event Type  Injury  
Manufacturer Narrative
The associated complaint devices were not returned for evaluation. Please see attached file for our results of investigation. (b)(4).
 
Manufacturer Narrative
Implantation date is an estimate because only the year was provided.
 
Event Description
It was reported that a revision surgery of the left hip was performed due to a peri prosthetic fracture of the proximal femur. Femoral stem, femoral head and liner were removed and replaced.
 
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Brand NameSYN POR PLUS HA HO STEM SZ 14
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCMNTD, METAL/POLYMER, NON-POROUS, C-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
markus poettker
1450 brooks road
memphis, TN 38116
MDR Report Key6874628
MDR Text Key107621375
Report Number1020279-2017-00755
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K002996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71309114
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2017
Was Device Evaluated by Manufacturer? No
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: 09/18/2017 Patient Sequence Number: 1
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