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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 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71337650
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); Joint Dislocation (2374); No Code Available (3191)
Event Date 03/04/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that patient underwent a revision surgery due to hip dislocation with femoral head and acetabular liner replaced with new devices.
 
Manufacturer Narrative
Correction based on date read from the actual device.
 
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Brand Name
R3 20 DEG XLPE ACET LNR 32MM X 50MM
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 Key6420138
MDR Text Key70409756
Report Number1020279-2017-00197
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeSF
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
Report Date 07/13/2017
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 Number71337650
Device Lot Number16GM17145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/06/2017
Initial Date FDA Received03/21/2017
Supplement Dates Manufacturer ReceivedNot provided
03/06/2017
Supplement Dates FDA Received04/12/2017
07/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2016
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
OXINIUM FEM HD 12/14 32MM-3: (B)(4)
Patient Outcome(s) Hospitalization; Required Intervention;
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