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	32	32
Insufficient Information	19	19
Device Dislodged or Dislocated	7	7
Difficult to Insert	6	6
Fracture	4	4
Separation Failure	3	3
Device Contamination with Chemical or Other Material	2	2
Unstable	2	2
Improper or Incorrect Procedure or Method	2	2
Appropriate Term/Code Not Available	2	2
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Difficult or Delayed Separation	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1
Difficult or Delayed Positioning	1	1
Positioning Failure	1	1
Material Erosion	1	1
Device Damaged Prior to Use	1	1
Loss of Osseointegration	1	1
Expiration Date Error	1	1
Migration or Expulsion of Device	1	1
Device Appears to Trigger Rejection	1	1
Device Slipped	1	1
Device Contaminated During Manufacture or Shipping	1	1
Naturally Worn	1	1
Malposition of Device	1	1
Biocompatibility	1	1
Detachment of Device or Device Component	1	1
Device Operates Differently Than Expected	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	23	23
Pain	14	14
Joint Dislocation	9	9
No Known Impact Or Consequence To Patient	8	8
No Code Available	6	6
No Consequences Or Impact To Patient	6	6
Bone Fracture(s)	5	5
No Clinical Signs, Symptoms or Conditions	5	5
No Information	4	4
Metal Related Pathology	3	3
Insufficient Information	3	3
Failure of Implant	3	3
Bacterial Infection	2	2
Injury	2	2
Fungal Infection	2	2
Fall	2	2
Reaction	2	2
Numbness	1	1
Unequal Limb Length	1	1
Irritability	1	1
Post Operative Wound Infection	1	1
Ambulation Difficulties	1	1
Hip Fracture	1	1
Osteolysis	1	1
Debris, Bone Shedding	1	1
Loss of Range of Motion	1	1
Inflammation	1	1