TPLC - Total Product Life Cycle

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Device	shoulder prosthesis, reverse configuration
Definition	Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
Product Code	PHX
Regulation Number	888.3660
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	6
ARTHROSURFACE INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	3
CATALYST ORTHOSCIENCE, INC
	SUBSTANTIALLY EQUIVALENT	1
CATALYST ORTHOSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	5
DEPUY (IRELAND)
	SUBSTANTIALLY EQUIVALENT	2
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	6
DEPUY ORTHOPAEDICS INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY(IRELAND)
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL, L.P.
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC
	SUBSTANTIALLY EQUIVALENT	3
FH INDUSTRIE
	SUBSTANTIALLY EQUIVALENT	2
FIX SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
FX SHOULDER USA, INC
	SUBSTANTIALLY EQUIVALENT	1
FX SHOULDER USA, INC.
	SUBSTANTIALLY EQUIVALENT	8
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE S.P.A
	SUBSTANTIALLY EQUIVALENT	2
LIMACORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	3
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	1
SHOULDER INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYMMETRY MEDICAL MANUFACTURING INC. DBA TECOMET, INC.
	SUBSTANTIALLY EQUIVALENT	1
TORNIER SAS
	SUBSTANTIALLY EQUIVALENT	1
TORNIER, INC.
	SUBSTANTIALLY EQUIVALENT	4
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	3
ZIMMER GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2441	2441
Device Dislodged or Dislocated	1435	1435
Appropriate Term/Code Not Available	1325	1325
Fracture	437	437
Unstable	340	340
Break	312	312
Loosening of Implant Not Related to Bone-Ingrowth	232	232
Detachment of Device or Device Component	197	197
Loose or Intermittent Connection	152	152
Osseointegration Problem	138	138
Patient Device Interaction Problem	122	122
Difficult to Insert	108	108
Insufficient Information	83	83
Naturally Worn	78	78
Migration	68	68
Device-Device Incompatibility	45	45
Microbial Contamination of Device	42	42
Malposition of Device	42	42
Positioning Failure	40	40
Device Appears to Trigger Rejection	34	34
Material Deformation	33	33
Loss of Osseointegration	32	32
Unintended Movement	29	29
No Apparent Adverse Event	28	28
Material Erosion	28	28
Positioning Problem	26	26
Inadequacy of Device Shape and/or Size	25	25
Noise, Audible	25	25
Defective Device	24	24
Material Separation	22	22
Improper or Incorrect Procedure or Method	22	22
Off-Label Use	16	16
Device Slipped	15	15
Material Integrity Problem	14	14
Therapeutic or Diagnostic Output Failure	13	13
Mechanical Jam	13	13
Biocompatibility	13	13
Difficult to Advance	13	13
Patient-Device Incompatibility	13	13
Migration or Expulsion of Device	12	12
Fitting Problem	12	12
Output Problem	10	10
Use of Device Problem	10	10
Mechanical Problem	9	9
Physical Resistance/Sticking	9	9
Difficult to Remove	9	9
Loss of or Failure to Bond	9	9
Material Fragmentation	9	9
Crack	8	8
Degraded	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1258	1258
Joint Dislocation	1258	1258
Insufficient Information	807	807
Pain	681	682
Failure of Implant	643	643
No Clinical Signs, Symptoms or Conditions	597	597
Joint Laxity	480	480
No Code Available	317	317
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	314	314
No Known Impact Or Consequence To Patient	225	225
Bone Fracture(s)	177	177
Fall	172	172
Inadequate Osseointegration	162	162
Implant Pain	162	162
Loss of Range of Motion	148	148
Osteolysis	68	68
Foreign Body In Patient	65	65
Subluxation	62	62
Osteopenia/ Osteoporosis	58	58
No Information	57	57
Hematoma	49	49
Unspecified Tissue Injury	47	47
Metal Related Pathology	47	47
Erosion	44	44
Bacterial Infection	34	34
Swelling/ Edema	34	34
Muscle/Tendon Damage	30	30
Nerve Damage	29	29
Inflammation	28	28
Discomfort	27	27
Ossification	27	27
Hypersensitivity/Allergic reaction	25	25
Adhesion(s)	21	21
Limited Mobility Of The Implanted Joint	21	21
Limb Fracture	21	21
Fever	19	19
Foreign Body Reaction	17	17
Pulmonary Embolism	17	17
Muscular Rigidity	17	17
Anemia	16	16
Sepsis	16	16
No Consequences Or Impact To Patient	16	16
Device Embedded In Tissue or Plaque	16	16
Scar Tissue	14	14
Numbness	14	14
Rheumatoid Arthritis	14	14
Impaired Healing	14	14
Synovitis	13	14
Joint Disorder	13	13
Cyst(s)	11	11