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	2
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	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	4624	4701
Device Dislodged or Dislocated	1132	1188
Fracture	1010	1058
Unstable	606	645
Loosening of Implant Not Related to Bone-Ingrowth	563	574
Appropriate Term/Code Not Available	454	460
Break	366	377
Patient Device Interaction Problem	290	293
Naturally Worn	273	273
Insufficient Information	271	278
Osseointegration Problem	243	255
Detachment of Device or Device Component	243	249
Migration	208	223
Loss of Osseointegration	192	192
Loose or Intermittent Connection	70	71
Malposition of Device	66	66
Mechanical Problem	62	62
Crack	43	44
Loss of or Failure to Bond	41	43
Noise, Audible	31	31
Material Fragmentation	28	28
Difficult to Insert	27	27
Material Integrity Problem	27	29
Material Twisted/Bent	26	26
Positioning Failure	25	26
Failure to Osseointegrate	23	23
Inadequacy of Device Shape and/or Size	23	23
Mechanical Jam	23	23
Biocompatibility	22	22
Degraded	20	21
Physical Resistance/Sticking	20	20
No Apparent Adverse Event	20	21
Defective Device	19	19
Lack of Effect	19	19
Use of Device Problem	19	19
Unintended Movement	18	18
Inaccurate Information	17	17
Migration or Expulsion of Device	17	17
Off-Label Use	16	16
Device Appears to Trigger Rejection	16	16
Material Erosion	16	17
Therapeutic or Diagnostic Output Failure	15	15
Device Difficult to Setup or Prepare	14	14
Material Separation	13	13
Fitting Problem	11	11
Difficult to Remove	10	10
Material Split, Cut or Torn	10	10
Material Deformation	10	10
Dull, Blunt	8	9
Device Damaged by Another Device	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1761	1798
No Clinical Signs, Symptoms or Conditions	1159	1188
Insufficient Information	1149	1213
Joint Dislocation	1138	1185
Failure of Implant	1040	1058
Joint Laxity	983	1008
Pain	973	983
Implant Pain	564	571
Bone Fracture(s)	506	519
Loss of Range of Motion	368	378
Inadequate Osseointegration	347	358
Osteolysis	301	302
Muscle/Tendon Damage	209	215
Fall	204	205
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	185	188
Limb Fracture	175	176
Subluxation	164	165
Bacterial Infection	129	130
Metal Related Pathology	114	118
Discomfort	94	95
Foreign Body In Patient	90	93
Erosion	86	88
Unspecified Tissue Injury	85	85
Post Operative Wound Infection	68	68
Swelling/ Edema	68	68
Ossification	62	62
Inflammation	46	47
Osteopenia/ Osteoporosis	42	42
Hematoma	42	42
Hypersensitivity/Allergic reaction	28	28
Muscle Weakness	27	27
Nerve Damage	26	26
Non-union Bone Fracture	21	21
Scar Tissue	20	20
Rheumatoid Arthritis	20	20
Rupture	19	19
Cyst(s)	18	18
No Information	17	17
Adhesion(s)	17	17
Ambulation Difficulties	17	17
Erythema	17	17
Fluid Discharge	16	16
Unspecified Musculoskeletal problem	15	15
Arthralgia	15	15
Numbness	14	14
Limited Mobility Of The Implanted Joint	14	14
Foreign Body Reaction	14	15
Device Overstimulation of Tissue	14	14
Pulmonary Embolism	14	14
Sepsis	13	13