TPLC - Total Product Life Cycle

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Device	prosthesis, hip, semi-constrained, metal/polymer, cemented
Regulation Description	Hip joint metal/polymer semi-constrained cemented prosthesis.
Product Code	JDI
Regulation Number	888.3350
Device Class	2

Premarket Reviews
Manufacturer	Decision
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP. A.K.A. STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	4
MICROPORT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ONKOS SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET
	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	3986	12034
Device Dislodged or Dislocated	1454	3053
Naturally Worn	1345	1359
Insufficient Information	601	686
Fracture	482	7142
Loosening of Implant Not Related to Bone-Ingrowth	413	8152
Degraded	401	408
Detachment of Device or Device Component	386	392
Break	315	317
Material Erosion	311	6264
Corroded	198	200
Osseointegration Problem	180	6125
Unstable	165	167
Difficult to Insert	147	149
Appropriate Term/Code Not Available	123	125
Migration	111	118
Noise, Audible	87	91
Material Twisted/Bent	81	81
Material Deformation	78	78
Use of Device Problem	75	75
Device Contaminated During Manufacture or Shipping	68	68
Loss of or Failure to Bond	66	68
Packaging Problem	63	63
Patient Device Interaction Problem	61	64
Loss of Osseointegration	60	61
Loose or Intermittent Connection	50	50
Mechanical Problem	44	46
Positioning Failure	43	43
Malposition of Device	39	6167
Connection Problem	37	37
Device Appears to Trigger Rejection	32	32
Tear, Rip or Hole in Device Packaging	30	30
Difficult to Remove	30	30
Off-Label Use	27	28
Biocompatibility	27	1792
Physical Resistance/Sticking	25	25
Failure to Osseointegrate	23	23
Incomplete or Inadequate Connection	21	21
Crack	21	21
Mechanical Jam	20	20
Material Fragmentation	19	19
Manufacturing, Packaging or Shipping Problem	18	18
Device-Device Incompatibility	18	19
Separation Failure	17	17
Inadequacy of Device Shape and/or Size	16	16
Premature Separation	16	16
Defective Device	15	15
Unintended Movement	15	15
No Apparent Adverse Event	14	15
Migration or Expulsion of Device	14	18

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	2183	8859
Insufficient Information	1540	9294
Joint Dislocation	1414	9137
No Clinical Signs, Symptoms or Conditions	1257	1264
Failure of Implant	1177	1370
Unspecified Infection	1017	8743
Metal Related Pathology	753	5826
Osteolysis	735	5616
Foreign Body Reaction	674	688
Joint Laxity	650	5035
Ambulation Difficulties	589	2185
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	523	531
Bone Fracture(s)	392	1490
Swelling/ Edema	293	303
Inadequate Osseointegration	287	289
Fall	228	231
Loss of Range of Motion	223	229
Discomfort	212	215
Synovitis	178	3471
Inflammation	176	177
Hypersensitivity/Allergic reaction	170	177
Implant Pain	162	163
Unspecified Tissue Injury	159	167
Scar Tissue	156	181
Ossification	88	3374
Physical Asymmetry	88	92
Muscle/Tendon Damage	80	84
Cyst(s)	78	80
Necrosis	76	3370
Bacterial Infection	67	68
Distress	67	71
Hematoma	66	68
Fluid Discharge	65	65
Unequal Limb Length	60	4938
Adhesion(s)	60	64
Nerve Damage	53	57
Fatigue	51	54
Hemorrhage/Bleeding	49	50
Impaired Healing	45	72
Thrombosis/Thrombus	41	41
Erythema	40	40
Wound Dehiscence	40	43
Limb Fracture	39	40
Fever	38	38
Osteopenia/ Osteoporosis	37	39
Post Operative Wound Infection	36	44
Emotional Changes	30	30
Hip Fracture	30	31
Deformity/ Disfigurement	29	7740
Sepsis	29	29