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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF NH HA SHELL SZ 52MM PRSTHSS,HP,SM-CNSTRND,UNCMNTD,MTL/POLYMER,NON-POROUS,CALICUM-PHOSPHATE

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SMITH & NEPHEW, INC. REF NH HA SHELL SZ 52MM PRSTHSS,HP,SM-CNSTRND,UNCMNTD,MTL/POLYMER,NON-POROUS,CALICUM-PHOSPHATE Back to Search Results
Catalog Number 71334252
Device Problem Unintended Movement (3026)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 10/22/2018
Event Type  Injury  
Event Description
It was reported that patient undergone revision thr surgery for recurrent dislocation.
 
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Brand NameREF NH HA SHELL SZ 52MM
Type of DevicePRSTHSS,HP,SM-CNSTRND,UNCMNTD,MTL/POLYMER,NON-POROUS,CALICUM-PHOSPHATE
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
sarah freestone
1450 brooks road
memphis, TN 38116
MDR Report Key8036165
MDR Text Key126061298
Report Number1020279-2018-02354
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K990666
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 03/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2011
Device Catalogue Number71334252
Device Lot Number01BM13433A
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 Received10/22/2018
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: 11/03/2018 Patient Sequence Number: 1
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