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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 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71337656
Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 06/08/2018
Event Type  Injury  
Event Description
Revision surgery was performed due to dislocation. The surgeon does not fault the device. The product is not available. No more information available.
 
Manufacturer Narrative
The associated complaint devices were not returned. The clinical/medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment. No medical assessment is warranted at this time. This complaint will be re-evaluated if more information becomes available. A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes. A review of complaint history for the listed parts revealed no prior complaints for the listed batches. Without the actual product involved, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened. We consider this investigation closed. Credit cannot be issued for the devices.
 
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Brand NameR3 20 DEG XLPE ACET LNR 32MM X 56MM
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
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
MDR Report Key7712727
MDR Text Key114796868
Report Number1020279-2018-01361
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
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 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71337656
Device Lot Number13LM03646
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 Received06/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/23/2018 Patient Sequence Number: 1
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