TPLC - Total Product Life Cycle

show TPLC since

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	2
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	4
STRYKER CORPORATION (TORNIER, INC.)
	SUBSTANTIALLY EQUIVALENT	2
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	1
TORNIER S.A.S.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4251	4328
Device Dislodged or Dislocated	1019	1073
Fracture	932	980
Unstable	518	557
Loosening of Implant Not Related to Bone-Ingrowth	504	515
Appropriate Term/Code Not Available	453	459
Break	351	362
Insufficient Information	255	262
Naturally Worn	242	242
Osseointegration Problem	229	241
Detachment of Device or Device Component	219	223
Migration	204	219
Loss of Osseointegration	130	130
Patient Device Interaction Problem	98	101
Loose or Intermittent Connection	70	71
Malposition of Device	63	63
Mechanical Problem	54	54
Crack	40	41
Loss of or Failure to Bond	37	39
Noise, Audible	31	31
Difficult to Insert	27	27
Material Fragmentation	26	26
Material Integrity Problem	26	28
Material Twisted/Bent	25	25
Positioning Failure	23	24
Mechanical Jam	22	22
Inadequacy of Device Shape and/or Size	22	22
Failure to Osseointegrate	21	21
Biocompatibility	19	19
No Apparent Adverse Event	19	20
Defective Device	19	19
Use of Device Problem	18	18
Inaccurate Information	17	17
Degraded	17	18
Migration or Expulsion of Device	17	17
Unintended Movement	17	17
Physical Resistance/Sticking	16	16
Material Erosion	16	17
Off-Label Use	15	15
Lack of Effect	15	15
Therapeutic or Diagnostic Output Failure	14	14
Device Appears to Trigger Rejection	13	13
Material Separation	13	13
Device Difficult to Setup or Prepare	12	12
Fitting Problem	11	11
Difficult to Remove	9	9
Material Deformation	9	9
Dull, Blunt	8	9
Material Split, Cut or Torn	8	8
Device Damaged by Another Device	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1556	1593
No Clinical Signs, Symptoms or Conditions	1080	1109
Joint Dislocation	1052	1097
Insufficient Information	1027	1091
Failure of Implant	980	998
Pain	904	914
Joint Laxity	848	873
Implant Pain	553	560
Bone Fracture(s)	413	426
Loss of Range of Motion	342	352
Inadequate Osseointegration	320	331
Osteolysis	233	234
Muscle/Tendon Damage	192	198
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	183	186
Limb Fracture	174	175
Fall	172	173
Bacterial Infection	128	129
Subluxation	126	127
Metal Related Pathology	95	99
Discomfort	92	93
Foreign Body In Patient	82	85
Erosion	81	83
Unspecified Tissue Injury	77	77
Swelling/ Edema	66	66
Ossification	53	53
Post Operative Wound Infection	46	46
Inflammation	45	46
Osteopenia/ Osteoporosis	42	42
Hematoma	40	40
Hypersensitivity/Allergic reaction	27	27
Nerve Damage	26	26
Muscle Weakness	24	24
Non-union Bone Fracture	21	21
Scar Tissue	19	19
No Information	17	17
Cyst(s)	17	17
Ambulation Difficulties	17	17
Erythema	17	17
Fluid Discharge	16	16
Arthralgia	15	15
Foreign Body Reaction	14	15
Limited Mobility Of The Implanted Joint	14	14
Numbness	14	14
Adhesion(s)	14	14
Pulmonary Embolism	14	14
Sepsis	13	13
Arthritis	12	12
Unspecified Musculoskeletal problem	12	12
Seroma	11	11
Rupture	11	11