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, LP
	SUBSTANTIALLY EQUIVALENT	3
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	2
TORNIER S.A.S.
	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	4664	4745
Device Dislodged or Dislocated	1277	1331
Fracture	1057	1105
Appropriate Term/Code Not Available	659	666
Loosening of Implant Not Related to Bone-Ingrowth	611	627
Unstable	541	580
Break	386	397
Insufficient Information	304	311
Naturally Worn	275	275
Detachment of Device or Device Component	267	271
Osseointegration Problem	236	248
Migration	221	236
Loss of Osseointegration	177	177
Loose or Intermittent Connection	122	123
Patient Device Interaction Problem	99	102
Malposition of Device	70	70
Difficult to Insert	55	55
Loss of or Failure to Bond	53	55
Mechanical Problem	47	47
Noise, Audible	36	36
Crack	36	37
Inadequacy of Device Shape and/or Size	35	35
Positioning Failure	33	34
Material Fragmentation	32	32
Material Twisted/Bent	29	29
Therapeutic or Diagnostic Output Failure	29	29
Mechanical Jam	27	27
Material Integrity Problem	27	29
Unintended Movement	26	26
Failure to Osseointegrate	22	22
Use of Device Problem	21	21
Biocompatibility	20	20
Migration or Expulsion of Device	20	20
Material Erosion	20	23
No Apparent Adverse Event	19	20
Device Difficult to Setup or Prepare	19	19
Defective Device	19	19
Material Separation	18	18
Inaccurate Information	17	17
Degraded	17	18
Physical Resistance/Sticking	17	17
Off-Label Use	16	16
Positioning Problem	15	15
Device Contaminated During Manufacture or Shipping	14	14
Device Appears to Trigger Rejection	13	13
Difficult to Remove	13	13
Lack of Effect	13	13
Material Deformation	12	12
Device-Device Incompatibility	12	12
Fitting Problem	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1758	1797
Joint Dislocation	1244	1289
Pain	1152	1170
No Clinical Signs, Symptoms or Conditions	1099	1128
Failure of Implant	1098	1121
Insufficient Information	1095	1159
Joint Laxity	832	857
Implant Pain	573	580
Bone Fracture(s)	464	477
No Code Available	387	387
Loss of Range of Motion	376	386
Inadequate Osseointegration	370	381
Osteolysis	238	239
Fall	236	237
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	219	222
Muscle/Tendon Damage	192	198
Limb Fracture	174	175
Bacterial Infection	143	144
Subluxation	125	126
Discomfort	110	111
No Information	101	101
No Known Impact Or Consequence To Patient	99	99
Metal Related Pathology	96	100
Erosion	95	97
Foreign Body In Patient	85	88
Unspecified Tissue Injury	71	71
Ossification	68	68
Injury	67	67
Swelling/ Edema	67	67
Hematoma	65	65
Limited Mobility Of The Implanted Joint	60	60
Inflammation	55	58
Post Operative Wound Infection	52	52
Osteopenia/ Osteoporosis	51	51
No Consequences Or Impact To Patient	46	46
Muscle Weakness	41	41
Tissue Damage	35	35
Hypersensitivity/Allergic reaction	29	29
Numbness	28	31
Foreign Body Reaction	27	28
Non-union Bone Fracture	27	27
Fluid Discharge	26	26
Nerve Damage	26	26
Erythema	25	25
Ambulation Difficulties	22	22
Adhesion(s)	22	22
Scar Tissue	22	22
Muscular Rigidity	21	21
Fever	20	20
Cyst(s)	18	18