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
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	3679	3725
Device Dislodged or Dislocated	1083	1128
Fracture	901	916
Appropriate Term/Code Not Available	658	658
Loosening of Implant Not Related to Bone-Ingrowth	478	480
Unstable	421	457
Break	357	368
Insufficient Information	246	246
Detachment of Device or Device Component	217	217
Migration	185	198
Naturally Worn	183	183
Osseointegration Problem	177	187
Loss of Osseointegration	158	158
Loose or Intermittent Connection	115	115
Patient Device Interaction Problem	81	81
Difficult to Insert	52	52
Malposition of Device	49	49
Loss of or Failure to Bond	41	41
Noise, Audible	33	33
Material Fragmentation	32	32
Inadequacy of Device Shape and/or Size	29	29
Therapeutic or Diagnostic Output Failure	27	27
Material Twisted/Bent	26	26
Positioning Failure	26	26
Material Integrity Problem	26	26
Unintended Movement	24	24
Mechanical Jam	23	23
Failure to Osseointegrate	21	21
Material Erosion	20	20
Material Separation	19	19
Use of Device Problem	19	19
Migration or Expulsion of Device	19	19
No Apparent Adverse Event	18	18
Crack	18	18
Mechanical Problem	16	16
Inaccurate Information	16	16
Degraded	15	15
Positioning Problem	14	14
Device Contaminated During Manufacture or Shipping	14	14
Device Difficult to Setup or Prepare	13	13
Difficult to Remove	12	12
Off-Label Use	12	12
Device-Device Incompatibility	12	12
Fitting Problem	11	11
Physical Resistance/Sticking	10	10
Biocompatibility	10	10
Material Deformation	10	10
Corroded	9	9
Packaging Problem	9	9
Device Damaged by Another Device	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1457	1481
Joint Dislocation	1029	1066
Failure of Implant	999	1006
No Clinical Signs, Symptoms or Conditions	943	943
Insufficient Information	878	925
Pain	862	862
Joint Laxity	612	634
Implant Pain	509	515
No Code Available	387	387
Bone Fracture(s)	336	346
Loss of Range of Motion	317	322
Inadequate Osseointegration	286	296
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	197	197
Fall	193	193
Osteolysis	167	167
Limb Fracture	162	162
Muscle/Tendon Damage	125	131
Bacterial Infection	120	120
No Information	102	102
No Known Impact Or Consequence To Patient	99	99
Discomfort	93	93
Erosion	83	83
Foreign Body In Patient	76	76
Subluxation	73	73
Metal Related Pathology	71	71
Injury	67	67
Ossification	62	62
Hematoma	59	59
Limited Mobility Of The Implanted Joint	59	59
Osteopenia/ Osteoporosis	51	51
No Consequences Or Impact To Patient	46	46
Unspecified Tissue Injury	42	42
Inflammation	42	42
Swelling/ Edema	40	40
Tissue Damage	35	35
Muscle Weakness	35	35
Numbness	28	28
Non-union Bone Fracture	27	27
Hypersensitivity/Allergic reaction	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
Scar Tissue	21	21
Ambulation Difficulties	21	21
Muscular Rigidity	20	20
Fever	20	20
Reaction	18	18