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	1
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	2
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
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	2870	2870
Device Dislodged or Dislocated	1394	1394
Appropriate Term/Code Not Available	1193	1193
Fracture	501	501
Unstable	376	376
Break	307	307
Loosening of Implant Not Related to Bone-Ingrowth	286	286
Detachment of Device or Device Component	244	244
Osseointegration Problem	155	155
Patient Device Interaction Problem	155	155
Loose or Intermittent Connection	131	131
Difficult to Insert	127	127
Naturally Worn	88	88
Migration	78	78
Insufficient Information	78	78
Positioning Failure	58	58
Device-Device Incompatibility	57	57
Device Appears to Trigger Rejection	43	43
Malposition of Device	43	43
Material Deformation	41	41
Unintended Movement	40	40
Microbial Contamination of Device	37	37
Loss of Osseointegration	36	36
No Apparent Adverse Event	32	32
Material Erosion	28	28
Defective Device	26	26
Noise, Audible	24	24
Improper or Incorrect Procedure or Method	23	23
Inadequacy of Device Shape and/or Size	23	23
Material Separation	21	21
Positioning Problem	21	21
Off-Label Use	16	16
Fitting Problem	15	15
Biocompatibility	13	13
Mechanical Jam	13	13
Use of Device Problem	13	13
Therapeutic or Diagnostic Output Failure	12	12
Degraded	10	10
Patient-Device Incompatibility	10	10
Mechanical Problem	10	10
Output Problem	10	10
Material Integrity Problem	9	9
Difficult to Advance	9	9
Crack	9	9
Difficult to Remove	8	8
Physical Resistance/Sticking	8	8
Corroded	7	7
Unexpected Therapeutic Results	7	7
Migration or Expulsion of Device	7	7
Device Difficult to Setup or Prepare	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	1407	1407
Unspecified Infection	1329	1329
Insufficient Information	895	895
No Clinical Signs, Symptoms or Conditions	719	719
Pain	695	696
Failure of Implant	692	692
Joint Laxity	614	614
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	317	317
No Code Available	240	240
Implant Pain	221	221
Inadequate Osseointegration	207	207
Bone Fracture(s)	190	190
Loss of Range of Motion	165	165
Fall	165	165
No Known Impact Or Consequence To Patient	111	111
Subluxation	77	77
Foreign Body In Patient	75	75
Osteolysis	74	74
Osteopenia/ Osteoporosis	64	64
Metal Related Pathology	54	54
Unspecified Tissue Injury	52	52
Hematoma	47	47
Erosion	46	46
Bacterial Infection	43	43
Swelling/ Edema	37	37
Nerve Damage	31	31
Muscle/Tendon Damage	30	30
No Information	29	29
Inflammation	28	28
Discomfort	27	27
Hypersensitivity/Allergic reaction	25	25
Ossification	25	25
Limb Fracture	22	22
Adhesion(s)	21	21
Foreign Body Reaction	21	21
Fever	19	19
Sepsis	17	17
Numbness	17	17
Limited Mobility Of The Implanted Joint	15	15
Muscular Rigidity	15	15
Scar Tissue	14	14
Rheumatoid Arthritis	14	14
Synovitis	13	14
Impaired Healing	13	13
Cyst(s)	11	11
Muscle Weakness	11	11
Swelling	10	11
Localized Skin Lesion	10	10
Post Operative Wound Infection	10	10
Wound Dehiscence	10	10