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
STRYKER CORPORATION (TORNIER, S.A.S.)
	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	2551	2551
Device Dislodged or Dislocated	1454	1454
Appropriate Term/Code Not Available	1325	1325
Fracture	446	446
Unstable	348	348
Break	320	320
Loosening of Implant Not Related to Bone-Ingrowth	236	236
Detachment of Device or Device Component	209	209
Loose or Intermittent Connection	152	152
Osseointegration Problem	142	142
Patient Device Interaction Problem	131	131
Difficult to Insert	112	112
Insufficient Information	83	83
Naturally Worn	80	80
Migration	73	73
Device-Device Incompatibility	47	47
Malposition of Device	42	42
Microbial Contamination of Device	42	42
Positioning Failure	41	41
Device Appears to Trigger Rejection	35	35
Material Deformation	35	35
Loss of Osseointegration	32	32
Unintended Movement	29	29
No Apparent Adverse Event	28	28
Material Erosion	28	28
Defective Device	26	26
Positioning Problem	26	26
Noise, Audible	25	25
Inadequacy of Device Shape and/or Size	25	25
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
Mechanical Jam	13	13
Therapeutic or Diagnostic Output Failure	13	13
Patient-Device Incompatibility	13	13
Biocompatibility	13	13
Difficult to Advance	13	13
Fitting Problem	12	12
Migration or Expulsion of Device	12	12
Use of Device Problem	10	10
Output Problem	10	10
Physical Resistance/Sticking	9	9
Mechanical Problem	9	9
Difficult to Remove	9	9
Material Fragmentation	9	9
Loss of or Failure to Bond	9	9
Crack	8	8
Degraded	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1311	1311
Joint Dislocation	1293	1293
Insufficient Information	822	822
Pain	682	683
Failure of Implant	654	654
No Clinical Signs, Symptoms or Conditions	608	608
Joint Laxity	502	502
No Code Available	317	317
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	315	315
No Known Impact Or Consequence To Patient	225	225
Bone Fracture(s)	180	180
Fall	172	172
Implant Pain	171	171
Inadequate Osseointegration	166	166
Loss of Range of Motion	151	151
Osteolysis	68	68
Foreign Body In Patient	66	66
Subluxation	64	64
Osteopenia/ Osteoporosis	58	58
No Information	57	57
Metal Related Pathology	50	50
Hematoma	49	49
Unspecified Tissue Injury	47	47
Erosion	45	45
Bacterial Infection	34	34
Swelling/ Edema	34	34
Nerve Damage	31	31
Muscle/Tendon Damage	30	30
Inflammation	28	28
Discomfort	27	27
Ossification	27	27
Hypersensitivity/Allergic reaction	25	25
Limb Fracture	22	22
Adhesion(s)	21	21
Limited Mobility Of The Implanted Joint	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
Muscle Weakness	11	11