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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

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SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120156
Device Problems Device Slipped (1584); Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348)
Event Date 05/14/2019
Event Type  Injury  
Event Description

It was reported that revision surgery was performed due to unexplained groin pain and a loose cup.

 
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Brand NameBHR ACETABULAR CUP 56MM
Type of DevicePROSTHESIS, 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
sarah freestone
MDR Report Key8614681
MDR Text Key145208556
Report Number3005975929-2019-00209
Device Sequence Number1
Product Code NXT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number74120156
Device LOT Number16EW12725
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/16/2019 Patient Sequence Number: 1
Treatment
FEMORAL HEAD, # 74121150, LOT # 16LW02712
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