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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN BHR DEVICE PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

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SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN BHR DEVICE PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120262
Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584); Unstable (1667); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
Event Date 11/04/2017
Event Type  Injury  
Event Description

It was reported that a revision surgery from the left hip was performed due to pain, loss of mobility, dislocation, loosening of the hip and metallosis.

 
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Brand NameUNKNOWN BHR DEVICE
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK CV31 3HL
Manufacturer Contact
sarah freestone
101 hessle road
hull HU32B-N
UK   HU32BN
MDR Report Key8295246
MDR Text Key134690638
Report Number3005975929-2019-00045
Device Sequence Number1
Product Code NXT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/31/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2010
Device Catalogue Number74120262
Device LOT Number53633
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/02/2005
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: 01/31/2019 Patient Sequence Number: 1
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