| Device |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive |
| Regulation Description |
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. |
| Definition |
Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use. |
| Product Code | OIY |
| Regulation Number |
888.3560
|
|---|
| Device Class |
2
|
| MDR Year |
MDR Reports |
MDR Events |
| 2021 |
379 |
379 |
| 2022 |
42 |
42 |
| 2023 |
40 |
40 |
| 2024 |
34 |
34 |
| 2025 |
37 |
37 |
| 2026 |
32 |
32 |
|
| Device Problems |
MDRs with this Device Problem |
Events in those MDRs |
| Adverse Event Without Identified Device or Use Problem |
368 |
368 |
| Unstable |
33 |
33 |
| Loss of or Failure to Bond |
28 |
28 |
| Fracture |
13 |
13 |
| Difficult to Insert |
10 |
10 |
| Patient Device Interaction Problem |
8 |
8 |
| Naturally Worn |
8 |
8 |
| Device Contaminated During Manufacture or Shipping |
7 |
7 |
| No Apparent Adverse Event |
5 |
5 |
| Loosening of Implant Not Related to Bone-Ingrowth |
4 |
4 |
| Use of Device Problem |
4 |
4 |
| Migration |
4 |
4 |
| Noise, Audible |
4 |
4 |
| Off-Label Use |
3 |
3 |
| Device Dislodged or Dislocated |
3 |
3 |
| Tear, Rip or Hole in Device Packaging |
3 |
3 |
| Device Damaged Prior to Use |
2 |
2 |
| Appropriate Device Problem Term/Code Not Available |
2 |
2 |
| Material Erosion |
2 |
2 |
| Detachment of Device or Device Component |
2 |
2 |
| Difficult to Open or Remove Packaging Material |
2 |
2 |
| Inaccurate Information |
1 |
1 |
| Manufacturing, Packaging or Shipping Problem |
1 |
1 |
| Inadequacy of Device Shape and/or Size |
1 |
1 |
| Defective Device |
1 |
1 |
| Degraded |
1 |
1 |
|
| Patient Problems |
MDRs with this Patient Problem |
Events in those MDRs |
| Pain |
154 |
154 |
| Joint Laxity |
130 |
130 |
| Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available |
81 |
81 |
| Unspecified Infection |
68 |
68 |
| Insufficient Information |
57 |
57 |
| Loss of Range of Motion |
49 |
49 |
| Adhesion(s) |
40 |
40 |
| Fall |
29 |
29 |
| No Clinical Signs, Symptoms or Conditions |
25 |
25 |
| Muscular Rigidity |
25 |
25 |
| Failure of Implant |
21 |
21 |
| Swelling/ Edema |
17 |
17 |
| Synovitis |
16 |
16 |
| Ambulation or Postural Difficulties |
16 |
16 |
| Implant Pain |
11 |
11 |
| Osteolysis |
10 |
10 |
| Scar Tissue |
9 |
9 |
| Inflammation |
9 |
9 |
| Discomfort |
8 |
8 |
| Bone Fracture(s) |
8 |
8 |
| Wound Dehiscence |
6 |
6 |
| Joint Dislocation |
5 |
5 |
| Muscle/Tendon Damage |
4 |
4 |
| Metal Related Pathology |
4 |
4 |
| Cyst(s) |
3 |
3 |
| Granuloma |
3 |
3 |
| Necrosis |
3 |
3 |
| Limb Fracture |
2 |
2 |
| Hematoma |
2 |
2 |
| Medical device site infection |
2 |
2 |
| Hypersensitivity/Allergic reaction |
2 |
2 |
| Foreign Body Reaction |
2 |
2 |
| Bursitis |
1 |
1 |
| Bone Notching |
1 |
1 |
| Fibrosis |
1 |
1 |
| Hemorrhage/Blood Loss/Bleeding |
1 |
1 |
| Rupture |
1 |
1 |
| Fluid Discharge |
1 |
1 |
| Nerve Damage |
1 |
1 |
| Damage to Ligament(s) |
1 |
1 |
| Sleep Dysfunction |
1 |
1 |
| Joint effusion |
1 |
1 |
| Tendinopathy |
1 |
1 |
| Myalgia |
1 |
1 |
| Fatigue |
1 |
1 |
| Retinal Tear |
1 |
1 |
| Extraskeletal ossification |
1 |
1 |
| Joint Contracture |
1 |
1 |
| Impaired Healing |
1 |
1 |
| Aseptic loosening |
1 |
1 |
|
|
|
