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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74122154
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Toxicity (2333); Ambulation Difficulties (2544)
Event Date 08/28/2018
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to: severe pain, limited mobility, elevated cobalt and chromium levels, and metallosis.
 
Manufacturer Narrative
Additional information received by the manufacturer has identified that this event is already contained in mdr 3005975929-2018-00325.Please disregard this mdr report.
 
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Brand Name
ACETABULAR CUP HAP SIZE 48/54
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa, CV313 HL
UK  CV313HL
MDR Report Key8020603
MDR Text Key125522514
Report Number3005975929-2018-00405
Device Sequence Number1
Product Code NXT
UDI-Device Identifier03596010552297
UDI-Public03596010552297
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 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number74122154
Device Lot Number08EW17229
Date Manufacturer Received10/08/2018
Patient Sequence Number1
Treatment
71357010/ANTHOLOGY SO POR PL HA SZ 10/08BM09320A; 74122548/HEMI HEAD 48MM/08FW17377; 74222100/MODULAR SLEEVE -4MM 12/14/08AW15248; 71357010/ANTHOLOGY SO POR PL HA SZ 10/08BM09320A; 74122548/HEMI HEAD 48MM/08FW17377; 74222100/MODULAR SLEEVE -4MM 12/14/08AW15248
Patient Outcome(s) Hospitalization; Required Intervention;
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