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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 1/31/2010
Device Problems Metal Shedding Debris (1804); Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); Seroma (2069); Complaint, Ill-Defined (2331)
Event Date 08/25/2015
Event Type  Injury  
Event Description
It was reported that left hip revision surgery was performed.During revision, two large fluid sacs were removed and the surgeon reported metallosis around the trunnion.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
 
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Brand Name
BHR ACETABULAR CUP 58MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key5034507
MDR Text Key24238087
Report Number3005477969-2015-00240
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 health professional
Type of Report Followup,Followup
Report Date 07/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number1/31/2010
Device Lot Number50721 025
Was Device Available for Evaluation? No
Date Manufacturer Received08/26/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DISTAL CENTRALIZER, # 71312410, LOT # UNKNOWN; FEMORAL STEM, # 71312362, LOT # UNKNOWN; MODULAR HEAD, # 74121550, LOT # UNKNOWN; MODULAR HEAD, # 74121550, LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age84 YR
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