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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

MDR Year MDR Reports MDR Events
2015 2 2
2017 1 1
2020 4 4
2022 114 114
2023 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 81 81
Loosening of Implant Not Related to Bone-Ingrowth 32 32
Migration 10 10
Device Dislodged or Dislocated 9 9
Break 5 5
Fracture 3 3
Out-Of-Box Failure 1 1
Material Integrity Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Osseointegration 32 32
Loss of Range of Motion 19 19
Joint Dislocation 18 18
Deformity/ Disfigurement 15 15
Erosion 8 8
Joint Laxity 8 8
Bone Fracture(s) 7 7
Unspecified Infection 7 7
Arthralgia 5 5
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 5 5
Muscle/Tendon Damage 4 4
Pain 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Subluxation 3 3
Hyperextension 2 2
Osteolysis 2 2
Discomfort 2 2
No Consequences Or Impact To Patient 2 2
Adhesion(s) 2 2
Ossification 1 1
Fall 1 1
Damage to Ligament(s) 1 1
Necrosis 1 1
Failure of Implant 1 1
Rupture 1 1
Urticaria 1 1
Post Operative Wound Infection 1 1
Foreign Body In Patient 1 1
Joint Contracture 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1

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