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

Premarket Reviews
Manufacturer	Decision
CORIN U.S.A.
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
MAXX ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	41	41
Insufficient Information	21	21
Device Dislodged or Dislocated	7	7
Difficult to Insert	6	6
Naturally Worn	5	5
Fracture	4	4
Separation Failure	3	3
Unstable	2	2
Device Contamination with Chemical or Other Material	2	2
Appropriate Term/Code Not Available	2	2
Improper or Incorrect Procedure or Method	2	2
Device Slipped	1	1
Device-Device Incompatibility	1	1
Device Contaminated During Manufacture or Shipping	1	1
Migration or Expulsion of Device	1	1
Malposition of Device	1	1
Device Damaged Prior to Use	1	1
Material Erosion	1	1
Unintended Movement	1	1
Expiration Date Error	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Positioning Failure	1	1
Difficult or Delayed Positioning	1	1
Difficult or Delayed Separation	1	1
Detachment of Device or Device Component	1	1
No Apparent Adverse Event	1	1
Device Operates Differently Than Expected	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	30	30
Pain	15	15
Joint Dislocation	9	9
No Known Impact Or Consequence To Patient	8	8
No Code Available	6	6
No Clinical Signs, Symptoms or Conditions	6	6
Insufficient Information	6	6
No Consequences Or Impact To Patient	6	6
Bone Fracture(s)	5	5
Failure of Implant	4	4
Metal Related Pathology	4	4
No Information	4	4
Fungal Infection	2	2
Injury	2	2
Fall	2	2
Reaction	2	2
Joint Laxity	2	2
Bacterial Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Debris, Bone Shedding	1	1
Hip Fracture	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
Osteolysis	1	1
Numbness	1	1
Unequal Limb Length	1	1
Irritability	1	1
Ambulation Difficulties	1	1