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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device metallic cemented glenoid hemi-shoulder prosthesis
Regulation Description Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Definition Call for pmas to be filed by 12/26/96 per 61 fr 50711 on 9/27/96
Product CodeKYM
Regulation Number 888.3680
Device Class 3

Device Problems
Loose 4
Disengaged 2
Dislocated 1
Failure to osseointegrate 1
No Known Device Problem 1
Component(s), worn 1
Total Device Problems 10

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