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?