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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, hinged (metal-metal)
Regulation Description Knee joint femorotibial metallic constrained cemented prosthesis.
Definition PMAs to be filed by 12/26/96 (61 FR 50710 (9/27/96))
Product CodeHRZ
Regulation Number 888.3480
Device Class 3

Device Problems
Break 12
Explanted 12
Loose 6
No Information 6
Fracture 5
Implant, removal of 3
No code available 2
Dislodged or dislocated 1
Incorrect device or component shipped 1
Disengaged 1
Device, or device fragments remain in patient 1
Fitting problem 1
Component missing 1
Total Device Problems 52

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