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
1. K200328 Tesera Trabecular Technologies (T3) Acetabular She ...
2. K201660 KMTI Hip Replacement System, Tesera Trabecular Tec ...
3. K203472 KMTI Hip Replacement System
MICROPORT ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	129	129
Adverse Event Without Identified Device or Use Problem	72	72
Device Contaminated During Manufacture or Shipping	68	68
Device Dislodged or Dislocated	45	45
Unstable	14	14
Packaging Problem	13	13
Fracture	10	10
Difficult to Insert	10	10
Patient Device Interaction Problem	10	10
Insufficient Information	9	9
Manufacturing, Packaging or Shipping Problem	9	9
Unintended Movement	8	8
Loosening of Implant Not Related to Bone-Ingrowth	6	6
Naturally Worn	5	5
Difficult or Delayed Positioning	5	5
Positioning Failure	5	5
Loose or Intermittent Connection	4	4
Microbial Contamination of Device	4	4
Detachment of Device or Device Component	4	4
Device Markings/Labelling Problem	3	3
Material Integrity Problem	3	3
Positioning Problem	3	3
Tear, Rip or Hole in Device Packaging	3	3
Product Quality Problem	3	3
Mechanical Problem	3	3
Migration or Expulsion of Device	2	2
Material Erosion	2	2
Break	2	2
Malposition of Device	2	2
Material Deformation	2	2
Migration	2	2
Unclear Information	1	1
Noise, Audible	1	1
Loss of or Failure to Bond	1	1
Improper or Incorrect Procedure or Method	1	1
Scratched Material	1	1
Therapeutic or Diagnostic Output Failure	1	1
Output Problem	1	1
Patient-Device Incompatibility	1	1
Activation, Positioning or Separation Problem	1	1
Device Appears to Trigger Rejection	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Computer Software Problem	1	1
Corroded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	117	117
No Patient Involvement	74	74
Pain	40	40
Joint Dislocation	36	36
No Known Impact Or Consequence To Patient	35	35
No Clinical Signs, Symptoms or Conditions	25	25
Insufficient Information	18	18
No Code Available	18	18
Failure of Implant	18	18
Loss of Range of Motion	9	9
Fall	6	6
Bone Fracture(s)	6	6
No Consequences Or Impact To Patient	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Joint Laxity	5	5
Metal Related Pathology	5	5
Joint Disorder	5	5
Ambulation Difficulties	5	5
Inflammation	4	4
Discomfort	3	3
Osteolysis	3	3
Bacterial Infection	3	3
Swelling	3	3
Synovitis	3	3
Limited Mobility Of The Implanted Joint	3	3
Implant Pain	3	3
No Information	3	3
Unequal Limb Length	2	2
Fluid Discharge	2	2
Foreign Body In Patient	2	2
Patient Problem/Medical Problem	2	2
Tissue Damage	2	2
Scar Tissue	2	2
Seroma	2	2
Ossification	2	2
Hip Fracture	2	2
Post Operative Wound Infection	2	2
Sleep Dysfunction	1	1
Necrosis	1	1
Blood Loss	1	1
Inadequate Osseointegration	1	1
Osteopenia/ Osteoporosis	1	1
Arthralgia	1	1
Impaired Healing	1	1
Numbness	1	1
Hematoma	1	1
Cellulitis	1	1
Wound Dehiscence	1	1
Host-Tissue Reaction	1	1
Tingling	1	1
Muscle/Tendon Damage	1	1
Skin Infection	1	1
Swelling/ Edema	1	1

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