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	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
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	3
STRYKER CORPORATION (TORNIER, INC.)
	SUBSTANTIALLY EQUIVALENT	2
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	4329	4375
Device Dislodged or Dislocated	1434	1479
Fracture	1039	1054
Appropriate Term/Code Not Available	773	773
Loosening of Implant Not Related to Bone-Ingrowth	592	594
Unstable	477	513
Break	414	425
Insufficient Information	379	379
Detachment of Device or Device Component	323	323
Naturally Worn	252	252
Loss of Osseointegration	221	221
Migration	217	230
Osseointegration Problem	199	209
Loose or Intermittent Connection	167	167
Difficult to Insert	99	99
Patient Device Interaction Problem	84	84
Loss of or Failure to Bond	76	76
Unintended Movement	76	76
Malposition of Device	66	66
Positioning Failure	42	42
Inadequacy of Device Shape and/or Size	41	41
Noise, Audible	38	38
Material Twisted/Bent	36	36
Material Fragmentation	34	34
Material Integrity Problem	30	30
Therapeutic or Diagnostic Output Failure	29	29
Material Erosion	28	28
Use of Device Problem	27	27
Mechanical Jam	26	26
No Apparent Adverse Event	25	25
Failure to Osseointegrate	23	23
Migration or Expulsion of Device	23	23
Mechanical Problem	23	23
Positioning Problem	22	22
Material Separation	21	21
Device-Device Incompatibility	21	21
Defective Device	19	19
Crack	18	18
Corroded	18	18
Difficult to Remove	18	18
Degraded	18	18
Inaccurate Information	17	17
Device Difficult to Setup or Prepare	17	17
Fitting Problem	16	16
Physical Resistance/Sticking	14	14
Off-Label Use	14	14
Device Contaminated During Manufacture or Shipping	14	14
Patient-Device Incompatibility	13	13
Material Split, Cut or Torn	11	11
Component Missing	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1842	1866
Joint Dislocation	1288	1325
Pain	1227	1227
Failure of Implant	1059	1066
No Code Available	979	979
No Clinical Signs, Symptoms or Conditions	971	971
Insufficient Information	904	951
Joint Laxity	635	657
Implant Pain	513	519
Bone Fracture(s)	443	453
Loss of Range of Motion	401	406
Inadequate Osseointegration	358	368
No Known Impact Or Consequence To Patient	261	261
No Information	229	229
Fall	224	224
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	202	202
Osteolysis	194	194
Injury	165	165
Patient Problem/Medical Problem	165	165
Limb Fracture	162	162
Muscle/Tendon Damage	139	145
Bacterial Infection	134	134
Discomfort	115	115
No Consequences Or Impact To Patient	106	106
Hematoma	104	104
Erosion	100	100
Not Applicable	91	91
Foreign Body In Patient	89	89
Limited Mobility Of The Implanted Joint	83	83
Ossification	82	82
Subluxation	78	78
Metal Related Pathology	77	77
Tissue Damage	64	64
Osteopenia/ Osteoporosis	56	56
Muscle Weakness	49	49
Inflammation	48	48
Muscular Rigidity	47	47
Unspecified Tissue Injury	43	43
Swelling/ Edema	40	40
Numbness	37	37
Swelling	36	36
Hypersensitivity/Allergic reaction	30	30
Nerve Damage	29	29
Non-union Bone Fracture	28	28
Foreign Body Reaction	28	28
Fluid Discharge	26	26
Reaction	25	25
Post Operative Wound Infection	25	25
Synovitis	25	25
Erythema	25	25