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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device high demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis
Definition For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: a) has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and b) needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/disloation secondary to damage or destruction of the articular cartilage.
Product CodeOMX
Device Class Humanitarian Device Exemption

Device Problems
Fracture 2
Out-of-box failure 1
Material integrity issue 1
Break 1
Detachment of device component 1
Total Device Problems 6