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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Model Number 71339552
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Joint Dislocation (2374)
Event Date 09/09/2016
Event Type  Injury  
Event Description
Revision surgery of left tha was performed due to repeated dislocation. The liner was replaced with new one.
 
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Brand NameR3 0 DEG XLPE ACET LNR 32MM X 52MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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
claudia de santis
schachenallee 29
aarau 5001
SZ   5001
0628320660
MDR Report Key5986217
MDR Text Key55874380
Report Number1020279-2016-00760
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K113848
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 09/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71339552
Device Catalogue Number71339552
Device Lot Number14JM02472
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 Received10/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/04/2014
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: 09/29/2016 Patient Sequence Number: 1
Treatment
ACETABULAR SHELL 52MM, (B)(4)
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