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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD44MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
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SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD44MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Back to Search Results
Catalog Number 74122544
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Swelling (2091); Toxicity (2333); Injury (2348)
Event Date 03/01/2019
Event Type  Injury  
Event Description
Patient submitted medwatch mw5086994 reports right hip revision due to pseudotumour, metal toxicity and dislocation.2 further revision surgeries reported on the right side, part details unknown.
 
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.
 
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Brand Name
HEMI HEAD44MM
Type of Device
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key8706573
MDR Text Key148257771
Report Number3005975929-2019-00250
Device Sequence Number1
Product Code KWL
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/24/2014
Device Catalogue Number74122544
Device Lot Number10BW12521
Was Device Available for Evaluation? No
Date Manufacturer Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
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