TPLC - Total Product Life Cycle

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Device	hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
Regulation Description	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
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	50	50
Insufficient Information	12	12
Naturally Worn	8	8
Device Dislodged or Dislocated	6	6
Separation Failure	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Fracture	2	2
Unstable	1	1
Device-Device Incompatibility	1	1
Device Damaged Prior to Use	1	1
Material Erosion	1	1
Expiration Date Error	1	1
Difficult to Insert	1	1
Positioning Failure	1	1
Difficult or Delayed Separation	1	1
Detachment of Device or Device Component	1	1
Device Appears to Trigger Rejection	1	1
Loss of Osseointegration	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	33	33
Insufficient Information	10	10
Pain	8	8
Joint Dislocation	7	7
No Clinical Signs, Symptoms or Conditions	6	6
Joint Laxity	5	5
Failure of Implant	4	4
Metal Related Pathology	4	4
No Known Impact Or Consequence To Patient	3	3
Fungal Infection	2	2
Bone Fracture(s)	2	2
Osteolysis	2	2
Fall	2	2
Bacterial Infection	2	2
Ambulation Difficulties	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
Inflammation	1	1
Implant Pain	1	1
Post Operative Wound Infection	1	1
Loss of Range of Motion	1	1
Unequal Limb Length	1	1
Fluid Discharge	1	1
Subluxation	1	1
Swelling/ Edema	1	1
No Consequences Or Impact To Patient	1	1
Irritability	1	1