TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ARTHREX INC
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	2
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	3
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
MATERIALISE NV
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	3
STRYKER CORPORATION (TORNIER, INC.)
	SUBSTANTIALLY EQUIVALENT	1
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	3
TECHMAH MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
TORNIER SAS
	SUBSTANTIALLY EQUIVALENT	2
TORNIER, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3943	3989
Device Dislodged or Dislocated	1364	1409
Fracture	952	967
Appropriate Term/Code Not Available	770	770
Loosening of Implant Not Related to Bone-Ingrowth	538	540
Unstable	414	450
Break	389	400
Insufficient Information	325	325
Detachment of Device or Device Component	308	308
Loss of Osseointegration	213	213
Naturally Worn	203	203
Migration	197	210
Osseointegration Problem	172	182
Loose or Intermittent Connection	166	166
Difficult to Insert	99	99
Patient Device Interaction Problem	78	78
Loss of or Failure to Bond	76	76
Unintended Movement	76	76
Malposition of Device	63	63
Positioning Failure	41	41
Inadequacy of Device Shape and/or Size	41	41
Noise, Audible	35	35
Material Twisted/Bent	33	33
Material Fragmentation	31	31
Therapeutic or Diagnostic Output Failure	29	29
Material Integrity Problem	28	28
Mechanical Jam	26	26
Use of Device Problem	25	25
Material Erosion	25	25
No Apparent Adverse Event	23	23
Migration or Expulsion of Device	23	23
Failure to Osseointegrate	23	23
Positioning Problem	22	22
Material Separation	21	21
Device-Device Incompatibility	21	21
Crack	18	18
Difficult to Remove	18	18
Inaccurate Information	16	16
Fitting Problem	16	16
Mechanical Problem	15	15
Degraded	15	15
Device Difficult to Setup or Prepare	15	15
Off-Label Use	14	14
Patient-Device Incompatibility	13	13
Physical Resistance/Sticking	13	13
Defective Device	11	11
Packaging Problem	11	11
Device Contaminated During Manufacture or Shipping	11	11
Component Missing	11	11
Failure to Align	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1711	1735
Joint Dislocation	1215	1252
Pain	1123	1123
Failure of Implant	988	995
No Code Available	979	979
No Clinical Signs, Symptoms or Conditions	883	883
Insufficient Information	823	870
Joint Laxity	525	547
Implant Pain	460	466
Bone Fracture(s)	390	400
Loss of Range of Motion	365	370
Inadequate Osseointegration	306	316
No Known Impact Or Consequence To Patient	261	261
No Information	229	229
Fall	196	196
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	191	191
Osteolysis	167	167
Injury	165	165
Patient Problem/Medical Problem	165	165
Limb Fracture	160	160
Bacterial Infection	133	133
No Consequences Or Impact To Patient	106	106
Discomfort	103	103
Hematoma	103	103
Erosion	97	97
Muscle/Tendon Damage	94	100
Not Applicable	91	91
Limited Mobility Of The Implanted Joint	83	83
Foreign Body In Patient	83	83
Ossification	82	82
Tissue Damage	64	64
Metal Related Pathology	57	57
Osteopenia/ Osteoporosis	56	56
Subluxation	55	55
Muscular Rigidity	47	47
Muscle Weakness	45	45
Unspecified Tissue Injury	41	41
Inflammation	38	38
Swelling/ Edema	37	37
Swelling	36	36
Numbness	33	33
Hypersensitivity/Allergic reaction	30	30
Nerve Damage	29	29
Non-union Bone Fracture	28	28
Fluid Discharge	26	26
Post Operative Wound Infection	25	25
Reaction	25	25
Erythema	25	25
Foreign Body Reaction	24	24
Adhesion(s)	23	23