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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Catalog Number 74122546
Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Toxicity (2333); Test Result (2695)
Event Date 07/22/2019
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to pain and high metal ion levels.
 
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.
 
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Brand Name
HEMI HEAD 46MM
Type of Device
PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key8825766
MDR Text Key152166100
Report Number3005975929-2019-00274
Device Sequence Number1
Product Code JDH
UDI-Device Identifier00885556071588
UDI-Public00885556071588
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number74122546
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODULAR SLEEVE, # 74222200, LOT # UNKNOWN; MODULAR SLEEVE, # 74222200, LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
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