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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120148
Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
Was reported to be (b)(6) 2017 which is deemed to be invalid information.Approximations per narrative reported to us.
 
Event Description
It was reported that in or about (b)(6) 2016 patient experienced pain, dysfunction and difficulties in the area of her right hip.It was deemed that hip failed and patient underwent revision surgery in (b)(6) 2017.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.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.
 
Event Description
Metallosis around the taper was noted, as well as large cysts behind the acetabulum.
 
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Brand Name
BHR ACETABULAR CUP 48MM
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 Key7107948
MDR Text Key94499634
Report Number3005975929-2017-00467
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 other
Type of Report Initial,Followup,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2012
Device Catalogue Number74120148
Device Lot Number74686
Was Device Available for Evaluation? No
Date Manufacturer Received12/08/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FEMORAL STEM, # 71357103, LOT # 07DM15619; HEMI HEAD, # 74122542, LOT # 10536; HIGHOFFSET ANTHOLOGY FEMORAL STEM,PART&LOT#UNKNOWN; MODULAR FEMORAL HEAD, PART AND LOT # UNKNOWN; MODULAR HEAD SLEEVE, PART AND LOT # UNKNOWN; MODULAR SLEEVE, # 74222200, LOT # 09634A; HIGHOFFSET ANTHOLOGY FEMORAL STEM,PART&LOT#UNKNOWN; MODULAR FEMORAL HEAD, PART AND LOT # UNKNOWN; MODULAR HEAD SLEEVE, PART AND LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
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