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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71335754
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); Joint Dislocation (2374); No Information (3190)
Event Date 12/09/2016
Event Type  Injury  
Event Description
It was reported to use that the patient underwent a revision surgery with change of the r3 insert and the ball head due to dislocation of the insert.The total hip replacement is a combination of polarstem/r3 acetabular shell.
 
Manufacturer Narrative
A correction based on new information produced.
 
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Brand Name
R3 20 DEG XLPE ACET LNR 36MM X 54MM
Type of Device
PROSTHESIS, 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 Key6295907
MDR Text Key66333481
Report Number1020279-2017-00078
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K113848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71335754
Device Lot Number15HM14296
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/09/2017
Initial Date FDA Received02/02/2017
Supplement Dates Manufacturer ReceivedNot provided
Not provided
04/24/2017
Supplement Dates FDA Received03/30/2017
04/25/2017
08/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
POLARSTEM FEMORAL STEM, PART&LOT#UNKNOWN; R3 ACETABULAR SHELL, PART&LOT#UNKNOWN; UNKNOWN FEMORAL BALL HEAD, PART&LOT#UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
Patient Weight72
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