DEPUY ASR XL
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Erin, Peanuts, JR, Daniel DEPUY ASR XL
description
DEPUY ASR XL. Erin, Peanuts, JR, Daniel. NEEDS. Decrease Pain Increase Mobility Improve quality of daily lifev. Alternate Solution. Absolutely nothing Recalled product. New Processes. Made a new product Better testing regulations Longer testing times. Prototypes. - PowerPoint PPT Presentation
Transcript of DEPUY ASR XL
Erin, Peanuts, JR, Daniel
DEPUY ASR XL
Decrease PainIncrease MobilityImprove quality of daily lifev
NEEDS
Absolutely nothingRecalled product
Alternate Solution
Made a new productBetter testing regulationsLonger testing times
New Processes
Two Earlier versionsPhased out after warning from FDA
Prototypes
Not many new problems due to recallLoosening of prosthesisMisalignmentNerve and Muscle damageFracturesMetal ions in bloodDislocationLawsuitsInconvenience of surgery
Current Problems
Implant didn’t go through clinical trialsConsidered a critical implantLooked like previous productResurfacing needed trialsDoctors could still use it off-label
Documentation
None reallyMore fractures occurred than expectedStill sold to doctorsPossible “kickbacks”
“Quality Control” Procedures
RecalledSome patients still use itMany replaced itNot improved upon, made other models
Is It Still Used?
Different amounts of stressDuration/ product life
Challenges
Stricter testing proceduresOutsiders witnessAll parts of product tested
Regulations
Critical implantAutomatic approvalCan sell off-label
Government Regulations
Not at faultDesign was the issueTesting not sufficient
Manufacturing Issues
Loosening of prosthesisMisalignmentNerve and Muscle damageFracturesMetal ions in bloodDislocationLawsuitsInconvenience of surgery
Safety Issues
Failure or Not?
