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	27	27
Device Dislodged or Dislocated	4	4
Insufficient Information	4	4
Separation Failure	3	3
Fracture	3	3
Expiration Date Error	1	1
Device Appears to Trigger Rejection	1	1
Unstable	1	1
Difficult or Delayed Separation	1	1
Appropriate Term/Code Not Available	1	1
Difficult or Delayed Positioning	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Positioning Failure	1	1
Loss of Osseointegration	1	1
Device-Device Incompatibility	1	1
Detachment of Device or Device Component	1	1
Naturally Worn	1	1
Biocompatibility	1	1
Material Erosion	1	1
Difficult to Insert	1	1
Device Damaged Prior to Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	16	16
Pain	6	6
Joint Dislocation	6	6
No Clinical Signs, Symptoms or Conditions	5	5
No Known Impact Or Consequence To Patient	4	4
Failure of Implant	3	3
Insufficient Information	3	3
Metal Related Pathology	3	3
Fungal Infection	2	2
Fall	2	2
Bacterial Infection	2	2
No Consequences Or Impact To Patient	2	2
Bone Fracture(s)	2	2
Irritability	1	1
Inflammation	1	1
Debris, Bone Shedding	1	1
Osteolysis	1	1
Unequal Limb Length	1	1