TPLC - Total Product Life Cycle

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Device	shoulder prosthesis, reverse configuration
Regulation Description	Shoulder joint metal/polymer semi-constrained cemented prosthesis.
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	5
ARTHROSURFACE, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MANUFACTURING CORP
	SUBSTANTIALLY EQUIVALENT	3
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	1
CATALYST ORTHOSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	6
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	6
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY(IRELAND)
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL, LP
	SUBSTANTIALLY EQUIVALENT	3
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	4
FH INDUSTRIE
	SUBSTANTIALLY EQUIVALENT	5
FIX SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
FX SHOULDER USA, INC.
	SUBSTANTIALLY EQUIVALENT	8
LIMA CORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	4
MEDACTA INERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	6
RESTOR3D
	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 S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
TORNIER, INC.
	SUBSTANTIALLY EQUIVALENT	3
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	3956	4062
Device Dislodged or Dislocated	1739	1759
Appropriate Term/Code Not Available	1190	1193
Fracture	695	714
Unstable	466	478
Loosening of Implant Not Related to Bone-Ingrowth	407	513
Break	361	365
Detachment of Device or Device Component	323	327
Patient Device Interaction Problem	247	250
Osseointegration Problem	204	208
Difficult to Insert	154	155
Loose or Intermittent Connection	132	132
Naturally Worn	129	179
Insufficient Information	98	107
Migration	93	96
Positioning Failure	83	84
Loss of Osseointegration	69	71
Device-Device Incompatibility	68	70
Device Appears to Trigger Rejection	64	64
Unintended Movement	57	57
Material Deformation	48	48
Malposition of Device	47	48
Defective Device	43	43
Material Erosion	42	42
Microbial Contamination of Device	37	37
Inadequacy of Device Shape and/or Size	35	36
No Apparent Adverse Event	34	43
Improper or Incorrect Procedure or Method	30	30
Noise, Audible	25	25
Material Separation	21	21
Positioning Problem	21	21
Mechanical Problem	20	20
Mechanical Jam	20	20
Use of Device Problem	16	16
Off-Label Use	16	16
Fitting Problem	16	16
Degraded	16	16
Therapeutic or Diagnostic Output Failure	13	13
Biocompatibility	13	13
Difficult to Advance	12	12
Crack	11	12
Patient-Device Incompatibility	11	11
Failure to Osseointegrate	11	11
Physical Resistance/Sticking	10	10
Output Problem	10	10
Material Twisted/Bent	9	9
Material Integrity Problem	9	9
Difficult to Remove	9	9
Migration or Expulsion of Device	8	8
Material Fragmentation	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	1899	1926
Unspecified Infection	1702	1722
Insufficient Information	1112	1150
No Clinical Signs, Symptoms or Conditions	991	1013
Pain	967	1115
Joint Laxity	904	1056
Failure of Implant	806	946
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	327	328
Bone Fracture(s)	302	308
Implant Pain	275	280
Inadequate Osseointegration	268	272
No Code Available	240	240
Loss of Range of Motion	235	378
Fall	170	170
Osteolysis	132	231
Subluxation	113	126
No Known Impact Or Consequence To Patient	111	111
Foreign Body In Patient	105	108
Metal Related Pathology	98	124
Osteopenia/ Osteoporosis	72	72
Bacterial Infection	64	64
Hematoma	58	58
Erosion	58	58
Unspecified Tissue Injury	53	53
Inflammation	46	163
Muscle/Tendon Damage	45	49
Discomfort	44	45
Swelling/ Edema	44	49
Nerve Damage	37	37
Muscle Weakness	35	159
Ossification	34	34
Hypersensitivity/Allergic reaction	32	37
Limb Fracture	30	30
No Information	29	30
Adhesion(s)	29	29
Fever	26	31
Non-union Bone Fracture	22	22
Unspecified Musculoskeletal problem	21	21
Post Operative Wound Infection	20	24
Foreign Body Reaction	18	19
Sepsis	17	17
Numbness	17	17
Limited Mobility Of The Implanted Joint	15	15
Muscular Rigidity	15	15
Thrombosis/Thrombus	15	15
Scar Tissue	15	15
Rheumatoid Arthritis	14	26
Malunion of Bone	13	13
Synovitis	13	14
Impaired Healing	13	13