TPLC - Total Product Life Cycle

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Device	prosthesis, shoulder, semi-constrained, metal/polymer cemented
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
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	3
STRYKER CORPORATION (TORNIER, INC.)
	SUBSTANTIALLY EQUIVALENT	1
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	3688	3734
Device Dislodged or Dislocated	1319	1364
Fracture	915	930
Appropriate Term/Code Not Available	771	771
Loosening of Implant Not Related to Bone-Ingrowth	503	505
Unstable	378	414
Break	378	389
Insufficient Information	319	319
Detachment of Device or Device Component	293	293
Loss of Osseointegration	195	195
Migration	194	207
Naturally Worn	191	191
Loose or Intermittent Connection	161	161
Osseointegration Problem	161	171
Difficult to Insert	99	99
Loss of or Failure to Bond	76	76
Unintended Movement	74	74
Patient Device Interaction Problem	72	72
Malposition of Device	63	63
Inadequacy of Device Shape and/or Size	41	41
Positioning Failure	40	40
Noise, Audible	35	35
Material Fragmentation	31	31
Material Twisted/Bent	31	31
Therapeutic or Diagnostic Output Failure	29	29
Material Erosion	25	25
Mechanical Jam	25	25
Use of Device Problem	25	25
Migration or Expulsion of Device	23	23
No Apparent Adverse Event	23	23
Failure to Osseointegrate	23	23
Positioning Problem	22	22
Material Separation	21	21
Device-Device Incompatibility	21	21
Material Integrity Problem	21	21
Difficult to Remove	18	18
Crack	17	17
Inaccurate Information	16	16
Device Difficult to Setup or Prepare	15	15
Fitting Problem	15	15
Mechanical Problem	15	15
Off-Label Use	14	14
Degraded	14	14
Patient-Device Incompatibility	13	13
Device Contaminated During Manufacture or Shipping	11	11
Failure to Align	11	11
Component Missing	11	11
Packaging Problem	11	11
Defective Device	11	11
Biocompatibility	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1618	1642
Joint Dislocation	1163	1200
Pain	1094	1094
No Code Available	979	979
Failure of Implant	932	939
No Clinical Signs, Symptoms or Conditions	833	833
Insufficient Information	782	829
Joint Laxity	476	498
Implant Pain	430	436
Bone Fracture(s)	377	387
Loss of Range of Motion	351	356
Inadequate Osseointegration	281	291
No Known Impact Or Consequence To Patient	260	260
No Information	229	229
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	191	191
Fall	190	190
Patient Problem/Medical Problem	165	165
Injury	165	165
Osteolysis	150	150
Limb Fracture	150	150
Bacterial Infection	130	130
No Consequences Or Impact To Patient	106	106
Hematoma	95	95
Erosion	94	94
Not Applicable	91	91
Discomfort	85	85
Limited Mobility Of The Implanted Joint	83	83
Foreign Body In Patient	83	83
Ossification	82	82
Muscle/Tendon Damage	76	82
Tissue Damage	64	64
Metal Related Pathology	57	57
Osteopenia/ Osteoporosis	52	52
Muscular Rigidity	47	47
Subluxation	45	45
Muscle Weakness	45	45
Unspecified Tissue Injury	39	39
Inflammation	37	37
Swelling	36	36
Swelling/ Edema	36	36
Hypersensitivity/Allergic reaction	34	34
Numbness	32	32
Nerve Damage	27	27
Fever	26	26
Non-union Bone Fracture	26	26
Reaction	25	25
Fluid Discharge	24	24
Foreign Body Reaction	24	24
Synovitis	22	22
Device Embedded In Tissue or Plaque	22	22