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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Model Number 74122552
Health Effect - Clinical Codes Pain (1994); No Code Available (3191)
Date of Event 06/05/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a left hip revision was performed due to painful metal-on-metal total hip arthroplasty, and trunnionosis.
 
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Brand Name
HEMI HEAD 52MM
Common Device Name
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 Key9955673
Report Number3005975929-2020-00107
Device Sequence Number2817624
Product Code NXT
UDI-Device Identifier00885556071694
UDI-Public00885556071694
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P040033
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date01/30/2014
Device Model Number74122552
Device Catalogue Number74122552
Device Lot Number09AW21009
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/26/2020
Supplement Date Received by Manufacturer03/26/2020
Initial Report FDA Received Date04/13/2020
Supplement Report FDA Received Date12/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ACETABULAR CUP 74122158/ 10JW30032; MODULAR SLEEVE 74222200/ 10CT40671; SYN POR FEM 71306618/ 00502920A
Outcome Attributed to Adverse Event Required Intervention;
Patient Age44 YR
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