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	1
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET INC.
	SUBSTANTIALLY EQUIVALENT	1
CATALYST ORTHOSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	4
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	4573	4624
Device Dislodged or Dislocated	1266	1311
Fracture	1034	1049
Appropriate Term/Code Not Available	658	658
Loosening of Implant Not Related to Bone-Ingrowth	598	600
Unstable	532	568
Break	385	396
Insufficient Information	298	298
Naturally Worn	271	271
Detachment of Device or Device Component	263	263
Osseointegration Problem	233	243
Migration	221	234
Loss of Osseointegration	166	166
Loose or Intermittent Connection	122	122
Patient Device Interaction Problem	100	100
Malposition of Device	57	57
Difficult to Insert	55	55
Loss of or Failure to Bond	52	52
Mechanical Problem	45	45
Noise, Audible	36	36
Inadequacy of Device Shape and/or Size	35	35
Positioning Failure	32	32
Material Fragmentation	32	32
Crack	32	32
Material Twisted/Bent	29	29
Therapeutic or Diagnostic Output Failure	29	29
Material Integrity Problem	27	27
Unintended Movement	26	26
Mechanical Jam	26	26
Use of Device Problem	21	21
Failure to Osseointegrate	21	21
Material Erosion	20	22
Migration or Expulsion of Device	20	20
Defective Device	19	19
No Apparent Adverse Event	19	19
Device Difficult to Setup or Prepare	19	19
Biocompatibility	18	18
Material Separation	18	18
Inaccurate Information	17	17
Physical Resistance/Sticking	17	17
Degraded	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
Device-Device Incompatibility	12	12
Material Deformation	12	12
Material Split, Cut or Torn	11	11
Fitting Problem	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1731	1757
Joint Dislocation	1232	1269
Pain	1121	1124
Failure of Implant	1093	1100
No Clinical Signs, Symptoms or Conditions	1084	1088
Insufficient Information	1056	1103
Joint Laxity	817	840
Implant Pain	567	573
Bone Fracture(s)	456	466
No Code Available	387	387
Inadequate Osseointegration	365	375
Loss of Range of Motion	363	368
Osteolysis	224	224
Fall	220	220
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	218	218
Muscle/Tendon Damage	189	195
Limb Fracture	174	174
Bacterial Infection	138	138
Subluxation	125	125
Discomfort	109	109
No Information	101	101
No Known Impact Or Consequence To Patient	99	99
Erosion	95	95
Metal Related Pathology	94	94
Foreign Body In Patient	85	85
Ossification	68	68
Injury	67	67
Unspecified Tissue Injury	67	67
Swelling/ Edema	67	67
Hematoma	64	64
Limited Mobility Of The Implanted Joint	60	60
Inflammation	55	57
Post Operative Wound Infection	52	52
Osteopenia/ Osteoporosis	51	51
No Consequences Or Impact To Patient	46	46
Muscle Weakness	40	40
Tissue Damage	35	35
Hypersensitivity/Allergic reaction	29	29
Numbness	28	31
Foreign Body Reaction	27	27
Non-union Bone Fracture	27	27
Fluid Discharge	26	26
Nerve Damage	25	25
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