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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 13 PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,NONPOROUS,CALICUM

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SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 13 PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,NONPOROUS,CALICUM Back to Search Results
Model Number 71309013
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Osteolysis (2377); Metal Related Pathology (4530)
Event Date 03/23/2020
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, after left bhr tha construct was implanted on (b)(6) 2010, the plaintiff experienced metallosis. A revision surgery was performed on (b)(6) 2020 to treat this adverse event. During the surgery, significant osteolysis was noted around the cup, as well as large collection of brown fluid. Plaintiff outcome is unknown.
 
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Brand NameSYN POR PLUS HA SO STEM SZ 13
Type of DevicePROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,NONPOROUS,CALICUM
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13100979
MDR Text Key284801738
Report Number1020279-2021-08919
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/03/2020
Device Model Number71309013
Device Catalogue Number71309013
Device Lot Number09MM02006A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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