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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
2024 1 1

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
Device Handling 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
No Clinical Signs, Symptoms or Conditions 4 4
Muscle/Tendon Damage 4 4
Pain 4 4
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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