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DEPUY ASR XL

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.

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DEPUY ASR XL

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  1. DEPUY ASR XL Erin, Peanuts, JR, Daniel

  2. NEEDS • Decrease Pain • Increase Mobility • Improve quality of daily lifev

  3. Alternate Solution • Absolutely nothing • Recalled product

  4. New Processes • Made a new product • Better testing regulations • Longer testing times

  5. Prototypes • Two Earlier versions • Phased out after warning from FDA

  6. Current Problems • Not many new problems due to recall • Loosening of prosthesis • Misalignment • Nerve and Muscle damage • Fractures • Metal ions in blood • Dislocation • Lawsuits • Inconvenience of surgery

  7. Documentation • Implant didn’t go through clinical trials • Considered a critical implant • Looked like previous product • Resurfacing needed trials • Doctors could still use it off-label

  8. “Quality Control” Procedures • None really • More fractures occurred than expected • Still sold to doctors • Possible “kickbacks”

  9. Is It Still Used? • Recalled • Some patients still use it • Many replaced it • Not improved upon, made other models

  10. Challenges • Different amounts of stress • Duration/ product life

  11. Regulations • Stricter testing procedures • Outsiders witness • All parts of product tested

  12. Government Regulations • Critical implant • Automatic approval • Can sell off-label

  13. Manufacturing Issues • Not at fault • Design was the issue • Testing not sufficient

  14. Safety Issues • Loosening of prosthesis • Misalignment • Nerve and Muscle damage • Fractures • Metal ions in blood • Dislocation • Lawsuits • Inconvenience of surgery

  15. Failure or Not?

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