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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120156
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 09/08/2015
Event Type  Injury  
Event Description
It was reported reason for revision is adverse reaction to metal-on-metal.Mri showed, "a significant amount of fluid around the lateral portion of the hip, no obvious muscle damage.".
 
Manufacturer Narrative
Date of event corrected.
 
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Brand Name
BHR ACETLR CUP HAP 56MM W/ IMPTR
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
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK   CV31 3HL
Manufacturer Contact
claudia odoy
schachenallee 29
aarau 5001
SZ   5001
0628320660
MDR Report Key6176793
MDR Text Key62474630
Report Number3005975929-2016-00067
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 04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date07/31/2013
Device Catalogue Number74120156
Device Lot Number090418
Was Device Available for Evaluation? No
Date Manufacturer Received12/10/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/11/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
HEMI HEAD#(B)(4), LOT#08JW18807; MODULAR SLEEVE#(B)(4), LOT#08GW17833; STEM#(B)(4), LOT#09EM10625
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
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