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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW BHR; ACETLR CUP HAP 52MM W/ IMPTR
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SMITH & NEPHEW BHR; ACETLR CUP HAP 52MM W/ IMPTR Back to Search Results
Catalog Number 74120152
Device Problem Device Slipped (1584)
Patient Problems Pain (1994); Toxicity (2333)
Event Date 03/05/2014
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to loosening, pain and elevated metal ion levels.
 
Manufacturer Narrative
 
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Brand Name
BHR
Type of Device
ACETLR CUP HAP 52MM W/ IMPTR
Manufacturer (Section D)
SMITH & NEPHEW
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW
aurora house
spa park
leamington spa CV31 3HL
UK   CV31 3HL
Manufacturer Contact
claudia odoy
schachenallee 29
aarau 5001
SZ   5001
4419264823
MDR Report Key4593600
MDR Text Key5482648
Report Number3005477969-2015-00080
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 Foreign,Consumer,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 03/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2013
Device Catalogue Number74120152
Device Lot Number085397
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2008
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
MODULAR HEAD, PART AND LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age79 YR
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