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	2
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	1
CATALYST ORTHOSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	2
DEPUY LNC.
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL L.P.
	SUBSTANTIALLY EQUIVALENT	3
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K212356 Exactech® Equinoxe® Laser Cage Glenoid
LIMACORPORATE
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	5
STRYKER CORPORATION (TORNIER, INC.)
	SUBSTANTIALLY EQUIVALENT	2
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	2
TORNIER S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
TORNIER, INC.
	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	5189	5266
Device Dislodged or Dislocated	1286	1342
Fracture	1140	1187
Unstable	653	691
Loosening of Implant Not Related to Bone-Ingrowth	628	643
Insufficient Device Problem Information	328	334
Patient Device Interaction Problem	320	323
Naturally Worn	309	309
Detachment of Device or Device Component	308	314
Osseointegration Problem	264	276
Break	252	263
Loss of Osseointegration	248	248
Migration	235	250
Malposition of Device	76	76
Mechanical Problem	63	63
Loss of or Failure to Bond	58	60
Difficult to Insert	57	57
Crack	43	44
Positioning Failure	37	38
Appropriate Device Problem Term/Code Not Available	36	38
Noise, Audible	33	33
Inadequacy of Device Shape and/or Size	31	31
Material Integrity Problem	28	30
Mechanical Jam	27	27
Unintended Movement	26	26
Material Fragmentation	26	26
Biocompatibility	24	24
Material Twisted/Bent	24	24
No Apparent Adverse Event	22	23
Failure to Osseointegrate	22	22
Use of Device Problem	21	21
Device Difficult to Setup or Prepare	21	21
Lack of Effect	20	20
Physical Resistance/Sticking	19	19
Material Erosion	19	20
Device Appears to Trigger Rejection	18	18
Off-Label Use	18	18
Defective Device	18	18
Degraded	18	19
Inaccurate Information	17	17
Migration or Expulsion of Device	16	16
Device Contaminated During Manufacture or Shipping	14	14
Material Deformation	13	13
Fitting Problem	11	11
Difficult to Remove	11	11
Device-Device Incompatibility	11	11
Packaging Problem	9	9
Dull, Blunt	8	9
Device Damaged by Another Device	8	8
Material Split, Cut or Torn	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	2077	2116
Joint Dislocation	1410	1457
Insufficient Information	1323	1387
Pain	1309	1327
No Clinical Signs, Symptoms or Conditions	1229	1258
Failure of Implant	1183	1206
Joint Laxity	1098	1123
Bone Fracture(s)	612	625
Implant Pain	592	599
Loss of Range of Motion	425	435
Inadequate Osseointegration	417	428
No Code Available	387	387
Osteolysis	329	330
Fall	284	285
Muscle/Tendon Damage	223	229
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	221	224
Limb Fracture	182	183
Subluxation	181	182
Medical device site infection	165	165
Bacterial Infection	150	151
Metal Related Pathology	134	138
Discomfort	118	119
Erosion	105	107
Post Operative Wound Infection	102	102
No Information	101	101
No Known Impact Or Consequence To Patient	97	97
Foreign Body In Patient	97	100
Unspecified Tissue Injury	92	92
Extraskeletal ossification	78	78
Joint Impingement	76	76
Swelling/ Edema	73	73
Aseptic loosening	70	71
Hematoma	69	69
Injury	67	67
Limited Mobility Of The Implanted Joint	60	60
Inflammation	59	62
Osteopenia/ Osteoporosis	51	51
No Consequences Or Impact To Patient	46	46
Muscle Weakness/Atrophy	46	46
Tissue Damage	35	35
Hypersensitivity/Allergic reaction	31	31
Fluid Discharge	30	30
Nerve Damage	29	29
Erythema	29	29
Numbness	28	31
Nonunion/Delayed-union Bone Fracture	28	28
Foreign Body Reaction	27	28
Adhesion(s)	25	25
Scar Tissue	25	25
Ambulation or Postural Difficulties	24	24