• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120158
Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Failure of Implant (1924); Inflammation (1932); Osteolysis (2377); Reaction (2414)
Event Date 06/16/2016
Event Type  Injury  
Event Description

It was reported that the right hip of a bilateral revision surgery was performed due to an adverse soft tissue reaction and moderate osteolysis.

 
Manufacturer Narrative

(b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBHR ACETABULAR CUP 58MM
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
markus poettker
schachenallee 29
aarau 5001
SZ   5001
MDR Report Key6727686
MDR Text Key80517917
Report Number3005975929-2017-00221
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 CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 03/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2012
Device Catalogue Number74120158
Device LOT Number077258
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 Received06/27/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/27/2007
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: 07/20/2017 Patient Sequence Number: 1
Treatment
FEMORAL STEM, # 71309012, LOT # 07FM00833A; HEMI HEAD, # 74122550, LOT # 11004; MODULAR SLEEVE, # 74222300, LOT # 9974
-
-