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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74122158
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Reaction (2414); Metal Related Pathology (4530)
Event Date 02/22/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced an adverse reaction to metal debris and that consequently a revision surgery is required, which will be performed in the next few months.
 
Event Description
Revision surgery was performed.
 
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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 LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key5365918
MDR Text Key35917416
Report Number3005477969-2016-00014
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 foreign,health professional,s
Type of Report Initial,Followup,Followup,Followup
Report Date 04/28/2021
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 Expiration Date04/30/2016
Device Catalogue Number74122158
Device Lot Number11DW32612 013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2016
Initial Date Manufacturer Received 01/05/2016
Initial Date FDA Received01/14/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
04/19/2021
Supplement Dates FDA Received02/25/2016
07/15/2016
04/28/2021
Patient Sequence Number1
Treatment
FEMORAL STEM, # 71352502, LOT # UNKNOWN; MODULAR HEAD, # 74222152, LOT # UNKNOWN; MODULAR NECK, # 71352111, LOT # UNKNOWN; MODULAR NECK, # 71352111, LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
Patient Weight79
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