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
AESCULAP IMPLANT SYSTEM, INC.
	SUBSTANTIALLY EQUIVALENT	1
CONSENSUS ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL, L.P.
	SUBSTANTIALLY EQUIVALENT	3
KYOCERA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
MICROPORT ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	1
NOVOSOURCE INC
	SUBSTANTIALLY EQUIVALENT	1
PIPELINE BIOMEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
PIPELINE ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
RENOVIS SURGICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
RENOVIS SURGICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
RENOVIS SURGICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
STELKAST COMPANY
	SUBSTANTIALLY EQUIVALENT	2
TOTAL JOINT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	137	137
Adverse Event Without Identified Device or Use Problem	104	104
Device Dislodged or Dislocated	83	83
Insufficient Information	74	74
Device Contaminated During Manufacture or Shipping	69	69
Unstable	26	26
Break	26	26
Fracture	18	18
Material Integrity Problem	17	17
Packaging Problem	14	14
Difficult to Insert	14	14
Patient Device Interaction Problem	10	10
Manufacturing, Packaging or Shipping Problem	9	9
Unintended Movement	8	8
Loose or Intermittent Connection	8	8
Inadequacy of Device Shape and/or Size	7	7
Material Deformation	7	7
Device Operates Differently Than Expected	7	7
Mechanical Problem	7	7
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Naturally Worn	6	6
Detachment of Device or Device Component	5	5
Difficult or Delayed Positioning	5	5
Positioning Failure	5	5
Microbial Contamination of Device	5	5
Positioning Problem	5	5
Malposition of Device	5	5
Device Slipped	5	5
Degraded	4	4
Contamination	3	3
Improper or Incorrect Procedure or Method	3	3
Device Markings/Labelling Problem	3	3
Migration or Expulsion of Device	3	3
Detachment Of Device Component	3	3
Difficult To Position	3	3
Product Quality Problem	3	3
Tear, Rip or Hole in Device Packaging	3	3
Scratched Material	2	2
Failure To Adhere Or Bond	2	2
Device Difficult to Setup or Prepare	2	2
Use of Device Problem	2	2
Material Erosion	2	2
Material Separation	2	2
Migration	2	2
Noise, Audible	2	2
Device Inoperable	1	1
Corroded	1	1
Device Or Device Fragments Location Unknown	1	1
Device Appears to Trigger Rejection	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	156	156
No Known Impact Or Consequence To Patient	82	82
No Patient Involvement	75	75
Joint Dislocation	63	63
No Code Available	59	59
Pain	56	56
No Consequences Or Impact To Patient	38	38
No Clinical Signs, Symptoms or Conditions	26	26
Injury	23	23
Failure of Implant	22	22
Insufficient Information	19	19
No Information	16	16
Fall	10	10
Loss of Range of Motion	10	10
Ambulation Difficulties	9	9
Bone Fracture(s)	9	9
Joint Laxity	8	8
Joint Disorder	6	6
Hip Fracture	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Limited Mobility Of The Implanted Joint	5	5
Metal Related Pathology	5	5
Discomfort	5	5
Inflammation	4	4
Synovitis	4	4
Bacterial Infection	3	3
Implant Pain	3	3
Fluid Discharge	3	3
Post Operative Wound Infection	3	3
Foreign Body In Patient	3	3
Scar Tissue	3	3
Swelling	3	3
Osteolysis	3	3
Tissue Damage	2	2
Ossification	2	2
Arthralgia	2	2
Seroma	2	2
Patient Problem/Medical Problem	2	2
Unequal Limb Length	2	2
Impaired Healing	1	1
Sleep Dysfunction	1	1
Swelling/ Edema	1	1
Host-Tissue Reaction	1	1
Muscle/Tendon Damage	1	1
Skin Infection	1	1
Wound Dehiscence	1	1
Numbness	1	1
Tingling	1	1
Staphylococcus Aureus	1	1
Cellulitis	1	1