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 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	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	6
DEPUY ORTHOPAEDICS INC.
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL, L.P.
	SUBSTANTIALLY EQUIVALENT	2
EXACTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC
	SUBSTANTIALLY EQUIVALENT	2
FH INDUSTRIE
	SUBSTANTIALLY EQUIVALENT	3
FIX SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
FX SHOULDER USA, INC
	SUBSTANTIALLY EQUIVALENT	1
FX SHOULDER USA, INC.
	SUBSTANTIALLY EQUIVALENT	7
LIMACORPORATE S.P.A
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	3
MEDACTA INERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	1
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 SAS
	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	3158	3158
Device Dislodged or Dislocated	1527	1527
Appropriate Term/Code Not Available	1196	1196
Fracture	563	563
Unstable	402	402
Loosening of Implant Not Related to Bone-Ingrowth	336	336
Break	326	326
Detachment of Device or Device Component	265	265
Patient Device Interaction Problem	190	190
Osseointegration Problem	158	158
Difficult to Insert	139	139
Loose or Intermittent Connection	132	132
Insufficient Information	96	100
Naturally Worn	94	94
Migration	83	83
Positioning Failure	63	63
Device-Device Incompatibility	60	60
Device Appears to Trigger Rejection	51	51
Unintended Movement	44	44
Malposition of Device	44	44
Material Deformation	42	42
Defective Device	39	39
Microbial Contamination of Device	37	37
Loss of Osseointegration	36	36
No Apparent Adverse Event	32	32
Material Erosion	28	28
Improper or Incorrect Procedure or Method	26	26
Noise, Audible	25	25
Inadequacy of Device Shape and/or Size	23	23
Material Separation	21	21
Positioning Problem	21	21
Fitting Problem	16	16
Off-Label Use	16	16
Mechanical Jam	16	16
Use of Device Problem	13	13
Biocompatibility	13	13
Therapeutic or Diagnostic Output Failure	13	13
Mechanical Problem	11	11
Degraded	11	11
Patient-Device Incompatibility	10	10
Output Problem	10	10
Crack	10	10
Material Integrity Problem	9	9
Difficult to Remove	9	9
Difficult to Advance	9	9
Migration or Expulsion of Device	8	8
Physical Resistance/Sticking	8	8
Dull, Blunt	7	7
Unexpected Therapeutic Results	7	7
Failure to Osseointegrate	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	1580	1580
Unspecified Infection	1429	1429
Insufficient Information	951	951
No Clinical Signs, Symptoms or Conditions	810	810
Pain	767	768
Failure of Implant	752	752
Joint Laxity	682	682
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	322	322
No Code Available	240	240
Implant Pain	234	234
Bone Fracture(s)	229	229
Inadequate Osseointegration	217	217
Loss of Range of Motion	173	173
Fall	168	168
No Known Impact Or Consequence To Patient	111	111
Subluxation	90	90
Foreign Body In Patient	85	85
Osteolysis	80	80
Osteopenia/ Osteoporosis	72	72
Metal Related Pathology	62	62
Hematoma	55	55
Unspecified Tissue Injury	52	52
Erosion	47	47
Bacterial Infection	43	43
Swelling/ Edema	40	40
Nerve Damage	32	32
Discomfort	32	32
Muscle/Tendon Damage	32	32
Inflammation	30	30
No Information	29	29
Ossification	27	27
Hypersensitivity/Allergic reaction	26	26
Fever	26	26
Foreign Body Reaction	24	24
Limb Fracture	23	23
Adhesion(s)	21	21
Sepsis	17	17
Numbness	17	17
Non-union Bone Fracture	17	17
Limited Mobility Of The Implanted Joint	15	15
Muscular Rigidity	15	15
Thrombosis/Thrombus	15	15
Scar Tissue	14	14
Rheumatoid Arthritis	14	14
Unspecified Musculoskeletal problem	13	13
Synovitis	13	14
Malunion of Bone	13	13
Impaired Healing	13	13
Cyst(s)	12	12
Muscle Weakness	11	11