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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74122154
Device Problems Loose or Intermittent Connection (1371); Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); Synovitis (2094); Osteolysis (2377)
Event Date 05/01/2017
Event Type  Injury  
Event Description
It was reported a right bhr revision surgery was performed due to acetabular osteolysis, synovitis and loosening.
 
Event Description
Right hip implanted device on or about 2009, explanted on about (b)(6) 2017.
 
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.- attachment: [288625 summary.Pdf].
 
Manufacturer Narrative
D4 udi added.
 
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Brand Name
ACETABLR CUP
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 Key9597378
MDR Text Key175257239
Report Number3005975929-2020-00020
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,other
Type of Report Initial,Followup,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number74122154
Date Manufacturer Received03/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FEMORAL STEM, PART AND LOT # UNKNOWN.; MODULAR HEAD, # 74222148, LOT # UNKNOWN.; MODULAR SLEEVE, # 74222300, LOT# UNKNOWN.
Patient Outcome(s) Hospitalization; Required Intervention;
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