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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 38MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 38MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74121138
Device Problems Corroded (1131); Appropriate Term/Code Not Available (3191)
Patient Problem Toxicity (2333)
Event Date 10/16/2019
Event Type  Injury  
Event Description
It was reported a left hip revision surgery was performed due to cobalt toxicity, metal corrosion particles, alval with large cystic tract all the way down to the hip joint itself and the head itself showed corrosion deep within the trunnion interspace.
 
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Brand Name
RESURFACING FEMORAL HEAD 38MM
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 Key9955729
MDR Text Key187508972
Report Number3005975929-2020-00109
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
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number74121138
Was Device Available for Evaluation? No
Date Manufacturer Received11/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
002002 COMPETITOR TO ALL OTHER HIPS.; 71331950 R3 3 HOLE HA CTD ACET SHELL 50MM.; 74222100 MODULAR SLEEVE -4MM 12/14.; BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI.
Patient Outcome(s) Required Intervention;
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