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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETABULAR CUP HAP SIZE 44/52
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETABULAR CUP HAP SIZE 44/52 Back to Search Results
Model Number 74122152
Device Problem Device Slipped (1584)
Patient Problems Pain (1994); Toxicity (2333)
Event Date 09/09/2014
Event Type  Injury  
Event Description
Pain revision surgery due to pain and loosening of the bhr cup (size 52) and bhr head (size 44).Elevated metal ions.Exact values were not supplied to manufacturer.
 
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Brand Name
BHR
Type of Device
ACETABULAR CUP HAP SIZE 44/52
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
1 kingmaker court
gallows hill CV34 6WG
Manufacturer (Section G)
SMITH & NEPHEW
aurora house
spa park
leamington spa CV31 3HL
UK   CV31 3HL
Manufacturer Contact
michael simmonds
oberneuhofstrasse 10d
baar
SZ   6340
4419264823
MDR Report Key4142495
MDR Text Key4769886
Report Number3005477969-2014-00519
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Invalid Data
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 03/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2012
Device Model Number74122152
Device Catalogue Number74122152
Device Lot Number07CW14705 006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received09/29/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/16/2008
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FEMORAL HEAD, # (B)(4), LOT # 11CW14070 025
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age57 YR
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