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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING; BHR ACETABULAR CUP 62MM
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SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING; BHR ACETABULAR CUP 62MM Back to Search Results
Catalog Number 74122162
Device Problems Material Disintegration (1177); Patient Device Interaction Problem (4001)
Patient Problems Host-Tissue Reaction (1297); Hypersensitivity/Allergic reaction (1907)
Event Date 05/01/2017
Event Type  Injury  
Event Description
It was reported that left hip revision surgery from smith and nephew devices was performed due to an adverse reaction to metal debris.
 
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Brand Name
BIRMINGHAM HIP RESURFACING
Type of Device
BHR ACETABULAR CUP 62MM
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa, warwickshire CV31 3HL
UK  CV31 3HL
MDR Report Key7913732
MDR Text Key121847318
Report Number3005975929-2018-00337
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/26/2013
Device Catalogue Number74122162
Device Lot Number08BW15707
Was Device Available for Evaluation? No
Date Manufacturer Received08/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FEMORAL STEM, # 71352502, LOT # 10BTM0018U; MODULAR HEAD, # 74222156, LOT # 07JW13571; MODULAR NECK, # 71352112, LOT # 09LTM0011A; MODULAR NECK, # 71352117, LOT # 09JTM0010B; MODULAR SLEEVE, # 74222100, LOT # 07LW14955; FEMORAL STEM, # 71352502, LOT # 10BTM0018U; MODULAR HEAD, # 74222156, LOT # 07JW13571; MODULAR NECK, # 71352112, LOT # 09LTM0011A; MODULAR NECK, # 71352117, LOT # 09JTM0010B; MODULAR SLEEVE, # 74222100, LOT # 07LW14955
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age52 YR
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