TPLC - Total Product Life Cycle

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Device	prosthesis, shoulder, semi-constrained, metal/polymer cemented
Regulation Description	Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Product Code	KWS
Regulation Number	888.3660
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARTHREX INC
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET INC.
	SUBSTANTIALLY EQUIVALENT	1
CATALYST ORTHOSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY LNC.
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL, L.P
	SUBSTANTIALLY EQUIVALENT	1
1. K222592 AltiVate® Anatomic Shoulder AG e+™ with Markers
ENCORE MEDICAL, L.P.
	SUBSTANTIALLY EQUIVALENT	2
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	3
STRYKER CORPORATION (TORNIER, INC.)
	SUBSTANTIALLY EQUIVALENT	2
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	2
TORNIER SAS
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3898	3944
Device Dislodged or Dislocated	1133	1178
Fracture	950	965
Appropriate Term/Code Not Available	659	659
Loosening of Implant Not Related to Bone-Ingrowth	508	510
Unstable	452	488
Break	373	384
Insufficient Information	262	262
Detachment of Device or Device Component	227	227
Naturally Worn	208	208
Osseointegration Problem	193	203
Migration	190	203
Loss of Osseointegration	158	158
Loose or Intermittent Connection	115	115
Patient Device Interaction Problem	85	85
Malposition of Device	56	56
Difficult to Insert	53	53
Loss of or Failure to Bond	42	42
Noise, Audible	34	34
Material Fragmentation	32	32
Inadequacy of Device Shape and/or Size	30	30
Material Twisted/Bent	27	27
Therapeutic or Diagnostic Output Failure	27	27
Positioning Failure	26	26
Material Integrity Problem	26	26
Unintended Movement	25	25
Mechanical Jam	25	25
Failure to Osseointegrate	21	21
Material Erosion	20	20
Material Separation	19	19
Use of Device Problem	19	19
No Apparent Adverse Event	19	19
Mechanical Problem	19	19
Migration or Expulsion of Device	19	19
Crack	19	19
Defective Device	18	18
Degraded	17	17
Inaccurate Information	17	17
Positioning Problem	14	14
Device Contaminated During Manufacture or Shipping	14	14
Device Difficult to Setup or Prepare	13	13
Physical Resistance/Sticking	12	12
Difficult to Remove	12	12
Off-Label Use	12	12
Biocompatibility	12	12
Device-Device Incompatibility	12	12
Fitting Problem	11	11
Material Deformation	11	11
Material Split, Cut or Torn	9	9
Corroded	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1530	1554
Joint Dislocation	1070	1107
Failure of Implant	1040	1047
No Clinical Signs, Symptoms or Conditions	987	987
Pain	937	937
Insufficient Information	924	971
Joint Laxity	661	683
Implant Pain	516	522
No Code Available	387	387
Bone Fracture(s)	374	384
Loss of Range of Motion	329	334
Inadequate Osseointegration	316	326
Fall	206	206
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	203	203
Osteolysis	173	173
Limb Fracture	163	163
Muscle/Tendon Damage	143	149
Bacterial Infection	120	120
No Information	102	102
No Known Impact Or Consequence To Patient	99	99
Discomfort	96	96
Subluxation	91	91
Erosion	84	84
Foreign Body In Patient	81	81
Metal Related Pathology	79	79
Injury	67	67
Ossification	62	62
Limited Mobility Of The Implanted Joint	59	59
Hematoma	59	59
Osteopenia/ Osteoporosis	51	51
No Consequences Or Impact To Patient	46	46
Unspecified Tissue Injury	46	46
Inflammation	43	43
Swelling/ Edema	40	40
Muscle Weakness	38	38
Tissue Damage	35	35
Numbness	28	28
Hypersensitivity/Allergic reaction	27	27
Non-union Bone Fracture	27	27
Fluid Discharge	26	26
Foreign Body Reaction	25	25
Erythema	24	24
Nerve Damage	23	23
Post Operative Wound Infection	23	23
Adhesion(s)	22	22
Ambulation Difficulties	22	22
Scar Tissue	21	21
Muscular Rigidity	20	20
Fever	20	20
Synovitis	18	18