TPLC - Total Product Life Cycle

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Device	hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
Definition	1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
Product Code	OQI
Regulation Number	888.3353
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	38	38
Insufficient Information	7	7
Naturally Worn	5	5
Device Dislodged or Dislocated	4	4
Fracture	3	3
Separation Failure	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Difficult or Delayed Separation	1	1
Appropriate Term/Code Not Available	1	1
Difficult or Delayed Positioning	1	1
Positioning Failure	1	1
Material Erosion	1	1
Biocompatibility	1	1
Detachment of Device or Device Component	1	1
Device-Device Incompatibility	1	1
Difficult to Insert	1	1
Device Appears to Trigger Rejection	1	1
Unstable	1	1
Device Damaged Prior to Use	1	1
Loss of Osseointegration	1	1
Expiration Date Error	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	26	26
Pain	7	7
Joint Dislocation	6	6
No Clinical Signs, Symptoms or Conditions	6	6
Insufficient Information	6	6
Failure of Implant	4	4
Metal Related Pathology	4	4
No Known Impact Or Consequence To Patient	4	4
Fungal Infection	2	2
Fall	2	2
Joint Laxity	2	2
Bacterial Infection	2	2
No Consequences Or Impact To Patient	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Wound Dehiscence	1	1
Debris, Bone Shedding	1	1
Cyst(s)	1	1
Bone Fracture(s)	1	1
Inflammation	1	1
Implant Pain	1	1
Osteolysis	1	1
Unequal Limb Length	1	1
Irritability	1	1