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	2
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4584	4674
Device Dislodged or Dislocated	1747	1767
Appropriate Term/Code Not Available	837	839
Fracture	790	809
Unstable	544	556
Loosening of Implant Not Related to Bone-Ingrowth	427	532
Patient Device Interaction Problem	345	347
Detachment of Device or Device Component	336	339
Break	295	298
Osseointegration Problem	236	240
Difficult to Insert	167	168
Naturally Worn	149	198
Insufficient Information	103	113
Migration	99	102
Positioning Failure	93	94
Loss of Osseointegration	86	87
Loose or Intermittent Connection	80	80
Device Appears to Trigger Rejection	78	78
Device-Device Incompatibility	68	70
Unintended Movement	60	60
Material Deformation	53	53
No Apparent Adverse Event	43	52
Defective Device	43	43
Malposition of Device	43	44
Material Erosion	42	42
Inadequacy of Device Shape and/or Size	37	38
Mechanical Jam	35	35
Microbial Contamination of Device	33	33
Improper or Incorrect Procedure or Method	31	31
Mechanical Problem	26	26
Noise, Audible	20	20
Use of Device Problem	19	19
Degraded	19	19
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
Output Problem	10	10
Physical Resistance/Sticking	10	10
Material Twisted/Bent	10	10
Material Integrity Problem	9	9
Crack	9	10
Migration or Expulsion of Device	8	8
Therapeutic or Diagnostic Output Failure	7	7
Difficult to Remove	7	7
Tear, Rip or Hole in Device Packaging	7	7
Lack of Effect	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Joint Dislocation	2075	2102
Unspecified Infection	1823	1843
Insufficient Information	1247	1274
No Clinical Signs, Symptoms or Conditions	1142	1164
Joint Laxity	1135	1287
Pain	979	1124
Failure of Implant	732	872
Bone Fracture(s)	384	389
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	305	306
Implant Pain	304	309
Inadequate Osseointegration	294	298
Loss of Range of Motion	277	419
Osteolysis	208	307
Subluxation	158	171
Fall	128	128
Foreign Body In Patient	111	114
Metal Related Pathology	110	136
Bacterial Infection	70	70
Osteopenia/ Osteoporosis	70	70
Unspecified Tissue Injury	61	61
Erosion	60	60
Hematoma	60	60
Inflammation	53	170
Discomfort	52	53
Muscle/Tendon Damage	48	51
Swelling/ Edema	44	49
Muscle Weakness	44	168
Nerve Damage	41	41
Post Operative Wound Infection	41	45
Ossification	41	41
Hypersensitivity/Allergic reaction	37	42
Limb Fracture	30	30
Adhesion(s)	29	29
Unspecified Musculoskeletal problem	26	26
Non-union Bone Fracture	25	25
Fever	21	26
Fluid Discharge	17	17
Scar Tissue	17	17
Numbness	17	17
Foreign Body Reaction	17	18
Muscular Rigidity	15	15
Thrombosis/Thrombus	15	15
Rheumatoid Arthritis	14	26
Malunion of Bone	13	13
Sepsis	12	12
Cyst(s)	12	12
Synovitis	12	12
Pulmonary Embolism	11	11
Localized Skin Lesion	10	15
Stroke/CVA	9	9