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
BIOMET ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
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	4
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
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	3
SHOULDER INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	4
STRYKER CORPORATION (TORNIER, INC.)
	SUBSTANTIALLY EQUIVALENT	1
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
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4616	4706
Device Dislodged or Dislocated	1460	1480
Fracture	780	799
Unstable	494	506
Loosening of Implant Not Related to Bone-Ingrowth	392	496
Patient Device Interaction Problem	362	364
Detachment of Device or Device Component	347	350
Osseointegration Problem	239	243
Break	177	180
Difficult to Insert	170	171
Naturally Worn	130	179
Positioning Failure	104	105
Migration	104	107
Insufficient Device Problem Information	94	104
Loss of Osseointegration	87	88
Device Appears to Trigger Rejection	81	81
Device-Device Incompatibility	68	70
Unintended Movement	61	61
Material Deformation	51	51
No Apparent Adverse Event	47	56
Malposition of Device	42	43
Material Erosion	40	40
Defective Device	40	40
Mechanical Jam	35	35
Microbial Contamination of Device	32	32
Appropriate Device Problem Term/Code Not Available	32	32
Mechanical Problem	29	29
Inadequacy of Device Shape and/or Size	27	28
Improper or Incorrect Procedure or Method	20	20
Noise, Audible	18	18
Failure to Osseointegrate	17	17
Use of Device Problem	17	17
Off-Label Use	17	17
Fitting Problem	16	16
Biocompatibility	14	14
Degraded	13	13
Difficult to Advance	12	12
Physical Resistance/Sticking	10	10
Material Integrity Problem	9	9
Crack	9	10
Tear, Rip or Hole in Device Packaging	8	8
Lack of Effect	8	8
Material Twisted/Bent	6	6
Component Missing	6	6
Device Difficult to Setup or Prepare	6	6
Material Fragmentation	6	6
Unexpected Therapeutic Results	6	6
Loss of or Failure to Bond	6	7
Dull, Blunt	6	7
Device Contaminated During Manufacture or Shipping	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	2160	2187
Unspecified Infection	1885	1905
Insufficient Information	1294	1321
Joint Laxity	1208	1360
No Clinical Signs, Symptoms or Conditions	1187	1209
Pain	1014	1159
Failure of Implant	737	877
Bone Fracture(s)	391	396
Medical device site infection	354	355
Implant Pain	312	317
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	305	306
Inadequate Osseointegration	301	305
Loss of Range of Motion	283	425
Osteolysis	208	307
Subluxation	159	172
Aseptic loosening	151	262
Fall	132	132
Foreign Body In Patient	120	123
Metal Related Pathology	111	137
Bacterial Infection	74	74
Osteopenia/ Osteoporosis	72	72
Joint Impingement	68	69
Erosion	62	62
Unspecified Tissue Injury	61	61
Hematoma	61	61
Discomfort	55	56
Muscle/Tendon Damage	54	57
Inflammation	54	171
Post Operative Wound Infection	48	52
Swelling/ Edema	48	53
Muscle Weakness/Atrophy	44	168
Nerve Damage	43	43
Extraskeletal ossification	41	41
Hypersensitivity/Allergic reaction	37	42
Radiolucent Lines	36	36
Bone Notching	34	34
Periprosthetic fracture	31	31
Limb Fracture	31	31
Adhesion(s)	29	29
Unspecified Musculoskeletal problem	27	27
Nonunion/Delayed-union Bone Fracture	26	26
Implant site sclerosis	21	158
Fever	21	26
Scar Tissue	18	18
Foreign Body Reaction	17	18
Fluid Discharge	17	17
Numbness	17	17
Thrombosis/Thrombus	16	16
Septic loosening	15	15
Muscular Rigidity	15	15