TPLC - Total Product Life Cycle

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Device	hip prosthesis, semi-constrained, cemented, metal/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	OQG
Regulation Number	888.3358
Device Class	2

Premarket Reviews
Manufacturer	Decision
KYOCERA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
MICROPORT ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	87	87
Adverse Event Without Identified Device or Use Problem	66	66
Device Contaminated During Manufacture or Shipping	62	62
Device Dislodged or Dislocated	39	39
Unstable	14	14
Packaging Problem	12	12
Manufacturing, Packaging or Shipping Problem	9	9
Difficult to Insert	9	9
Unintended Movement	8	8
Patient Device Interaction Problem	7	7
Loosening of Implant Not Related to Bone-Ingrowth	5	5
Fracture	5	5
Positioning Failure	4	4
Difficult or Delayed Positioning	4	4
Mechanical Problem	3	3
Material Integrity Problem	3	3
Positioning Problem	3	3
Microbial Contamination of Device	3	3
Product Quality Problem	3	3
Tear, Rip or Hole in Device Packaging	3	3
Naturally Worn	3	3
Loose or Intermittent Connection	3	3
Break	2	2
Migration or Expulsion of Device	2	2
Device Markings/Labelling Problem	2	2
Material Erosion	2	2
Insufficient Information	2	2
Material Deformation	2	2
Detachment of Device or Device Component	2	2
Migration	2	2
Activation, Positioning or Separation Problem	1	1
Malposition of Device	1	1
Output Problem	1	1
Patient-Device Incompatibility	1	1
Unclear Information	1	1
Material Separation	1	1
Device Appears to Trigger Rejection	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of or Failure to Bond	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	79	79
No Patient Involvement	71	71
Joint Dislocation	28	28
Pain	27	27
No Clinical Signs, Symptoms or Conditions	25	25
Insufficient Information	19	19
No Known Impact Or Consequence To Patient	18	18
Failure of Implant	16	16
No Code Available	14	14
Joint Laxity	11	11
Loss of Range of Motion	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Fall	5	5
Metal Related Pathology	5	5
Ambulation Difficulties	4	4
Bone Fracture(s)	4	4
Inflammation	4	4
Synovitis	3	3
Implant Pain	3	3
Joint Disorder	3	3
Discomfort	3	3
Osteolysis	3	3
No Consequences Or Impact To Patient	3	3
Post Operative Wound Infection	2	2
Seroma	2	2
Unequal Limb Length	2	2
Bacterial Infection	2	2
Patient Problem/Medical Problem	2	2
Hematoma	1	1
Necrosis	1	1
No Information	1	1
Osteopenia/ Osteoporosis	1	1
Inadequate Osseointegration	1	1
Cellulitis	1	1
Foreign Body In Patient	1	1
Swelling	1	1
Hip Fracture	1	1
Wound Dehiscence	1	1
Impaired Healing	1	1
Sleep Dysfunction	1	1
Fluid Discharge	1	1
Muscle/Tendon Damage	1	1
Skin Infection	1	1
Swelling/ Edema	1	1
Tissue Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Conformis, Inc.	II	Aug-16-2023