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	3793	3839
Device Dislodged or Dislocated	1107	1152
Fracture	929	944
Appropriate Term/Code Not Available	659	659
Loosening of Implant Not Related to Bone-Ingrowth	487	489
Unstable	432	468
Break	367	378
Insufficient Information	255	255
Detachment of Device or Device Component	220	220
Naturally Worn	199	199
Migration	189	202
Osseointegration Problem	185	195
Loss of Osseointegration	158	158
Loose or Intermittent Connection	115	115
Patient Device Interaction Problem	84	84
Difficult to Insert	52	52
Malposition of Device	51	51
Loss of or Failure to Bond	41	41
Noise, Audible	34	34
Material Fragmentation	32	32
Inadequacy of Device Shape and/or Size	29	29
Material Twisted/Bent	27	27
Therapeutic or Diagnostic Output Failure	27	27
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
No Apparent Adverse Event	19	19
Mechanical Problem	19	19
Migration or Expulsion of Device	19	19
Crack	18	18
Degraded	17	17
Inaccurate Information	17	17
Defective Device	16	16
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
Physical Resistance/Sticking	11	11
Fitting Problem	11	11
Biocompatibility	10	10
Material Deformation	10	10
Material Split, Cut or Torn	9	9
Corroded	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1494	1518
Joint Dislocation	1053	1090
Failure of Implant	1015	1022
No Clinical Signs, Symptoms or Conditions	971	971
Insufficient Information	903	950
Pain	887	887
Joint Laxity	634	656
Implant Pain	513	519
No Code Available	387	387
Bone Fracture(s)	357	367
Loss of Range of Motion	325	330
Inadequate Osseointegration	303	313
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	201	201
Fall	197	197
Osteolysis	170	170
Limb Fracture	162	162
Muscle/Tendon Damage	139	145
Bacterial Infection	120	120
No Information	102	102
No Known Impact Or Consequence To Patient	99	99
Discomfort	95	95
Erosion	83	83
Subluxation	78	78
Foreign Body In Patient	78	78
Metal Related Pathology	76	76
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	43	43
Inflammation	43	43
Swelling/ Edema	40	40
Muscle Weakness	37	37
Tissue Damage	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