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	3
ARTHROSURFACE, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MANUFACTURING CORP
	SUBSTANTIALLY EQUIVALENT	3
CATALYST ORTHOSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	6
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	6
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL L.P.
	SUBSTANTIALLY EQUIVALENT	4
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	3
FH INDUSTRIE
	SUBSTANTIALLY EQUIVALENT	6
FIX SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
FX SHOULDER USA, INC.
	SUBSTANTIALLY EQUIVALENT	5
LIMA CORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	4
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	6
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	1
SHOULDER INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	3
STRYKER CORPORATION (TORNIER, S.A.S.)
	SUBSTANTIALLY EQUIVALENT	2
SYMMETRY MEDICAL MANUFACTURING INC. DBA TECOMET, INC.
	SUBSTANTIALLY EQUIVALENT	1
TORNIER S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
TORNIER, INC.
	SUBSTANTIALLY EQUIVALENT	4
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4370	4462
Device Dislodged or Dislocated	1651	1671
Appropriate Term/Code Not Available	837	839
Fracture	748	767
Unstable	504	516
Loosening of Implant Not Related to Bone-Ingrowth	404	509
Detachment of Device or Device Component	318	321
Break	293	296
Patient Device Interaction Problem	272	274
Osseointegration Problem	222	226
Difficult to Insert	162	163
Naturally Worn	145	194
Migration	95	98
Insufficient Information	93	103
Positioning Failure	88	89
Loss of Osseointegration	80	81
Loose or Intermittent Connection	80	80
Device Appears to Trigger Rejection	72	72
Device-Device Incompatibility	68	70
Unintended Movement	60	60
Material Deformation	52	52
Defective Device	43	43
Material Erosion	42	42
Malposition of Device	41	42
No Apparent Adverse Event	39	48
Inadequacy of Device Shape and/or Size	36	37
Mechanical Jam	35	35
Microbial Contamination of Device	33	33
Improper or Incorrect Procedure or Method	31	31
Mechanical Problem	25	25
Noise, Audible	20	20
Degraded	18	18
Use of Device Problem	18	18
Off-Label Use	17	17
Failure to Osseointegrate	17	17
Material Separation	16	16
Fitting Problem	16	16
Biocompatibility	14	14
Difficult to Advance	12	12
Positioning Problem	10	10
Physical Resistance/Sticking	10	10
Output Problem	10	10
Material Integrity Problem	9	9
Material Twisted/Bent	9	9
Crack	8	9
Therapeutic or Diagnostic Output Failure	7	7
Difficult to Remove	7	7
Migration or Expulsion of Device	7	7
Lack of Effect	7	7
Unexpected Therapeutic Results	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	1978	2005
Unspecified Infection	1764	1784
Insufficient Information	1150	1177
No Clinical Signs, Symptoms or Conditions	1096	1118
Joint Laxity	1066	1218
Pain	947	1092
Failure of Implant	727	867
Bone Fracture(s)	342	347
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	305	306
Implant Pain	295	300
Inadequate Osseointegration	279	283
Loss of Range of Motion	256	398
Osteolysis	181	280
Subluxation	150	163
Fall	121	121
Foreign Body In Patient	107	110
Metal Related Pathology	105	131
Bacterial Infection	70	70
Osteopenia/ Osteoporosis	70	70
Hematoma	60	60
Unspecified Tissue Injury	59	59
Erosion	57	57
Discomfort	51	52
Muscle/Tendon Damage	47	50
Inflammation	46	163
Swelling/ Edema	44	49
Muscle Weakness	40	164
Ossification	38	38
Nerve Damage	36	36
Hypersensitivity/Allergic reaction	35	40
Post Operative Wound Infection	34	38
Limb Fracture	30	30
Adhesion(s)	29	29
Non-union Bone Fracture	25	25
Unspecified Musculoskeletal problem	23	23
Fever	21	26
Scar Tissue	17	17
Fluid Discharge	17	17
Foreign Body Reaction	17	18
Muscular Rigidity	15	15
Thrombosis/Thrombus	15	15
Rheumatoid Arthritis	14	26
Malunion of Bone	13	13
Cyst(s)	12	12
Synovitis	12	12
Sepsis	11	11
Pulmonary Embolism	11	11
Localized Skin Lesion	10	15
Numbness	9	9
Stroke/CVA	9	9