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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 52MM REF. 3 ACETABULAR SYSTEM

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SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 52MM REF. 3 ACETABULAR SYSTEM Back to Search Results
Catalog Number 71331852
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Joint Dislocation (2374)
Event Date 03/31/2016
Event Type  Injury  
Manufacturer Narrative
Udi# (b)(4). Customer indicated that there is no product/device to be returned for investigation analysis.
 
Event Description
It was reported a revision surgery was performed due to implant dislocation.
 
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Brand NameR3 0 HOLE ACET SHELL 52MM
Type of DeviceREF. 3 ACETABULAR SYSTEM
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
yagna angirish
1450 brooks rd
memphis, TN 38116
9013995009
MDR Report Key5541580
MDR Text Key41664450
Report Number1020279-2016-00275
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
PMA/PMN Number
K070756
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 03/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71331852
Device Lot Number13EM20275
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2013
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: 04/01/2016 Patient Sequence Number: 1
Treatment
71336500/14DM12337
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