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	4238	13086
Device Dislodged or Dislocated	1507	3106
Naturally Worn	1393	1408
Insufficient Information	618	702
Fracture	536	7977
Loosening of Implant Not Related to Bone-Ingrowth	447	8966
Detachment of Device or Device Component	415	421
Degraded	412	419
Material Erosion	327	7061
Break	319	321
Corroded	198	200
Osseointegration Problem	194	6920
Unstable	182	184
Difficult to Insert	159	161
Migration	124	131
Appropriate Term/Code Not Available	123	125
Noise, Audible	88	92
Material Twisted/Bent	85	85
Use of Device Problem	78	78
Material Deformation	78	78
Loss of Osseointegration	72	73
Loss of or Failure to Bond	69	71
Device Contaminated During Manufacture or Shipping	68	68
Patient Device Interaction Problem	64	67
Packaging Problem	63	63
Loose or Intermittent Connection	51	51
Positioning Failure	50	50
Malposition of Device	46	6955
Mechanical Problem	45	47
Connection Problem	37	37
Device Appears to Trigger Rejection	35	35
Tear, Rip or Hole in Device Packaging	34	34
Difficult to Remove	30	30
Off-Label Use	27	28
Biocompatibility	27	1792
Physical Resistance/Sticking	25	25
Failure to Osseointegrate	24	24
Crack	22	22
Incomplete or Inadequate Connection	21	21
Mechanical Jam	20	20
Material Fragmentation	19	19
Inadequacy of Device Shape and/or Size	18	18
Manufacturing, Packaging or Shipping Problem	18	18
Separation Failure	18	18
Device-Device Incompatibility	18	19
Premature Separation	16	16
Defective Device	15	15
Unintended Movement	15	15
No Apparent Adverse Event	15	16
Delivered as Unsterile Product	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	2306	9762
Insufficient Information	1673	10210
Joint Dislocation	1478	9982
No Clinical Signs, Symptoms or Conditions	1316	1323
Failure of Implant	1181	1374
Unspecified Infection	1075	9582
Metal Related Pathology	790	6645
Osteolysis	779	6442
Joint Laxity	691	5857
Foreign Body Reaction	690	704
Ambulation Difficulties	640	2236
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	530	538
Bone Fracture(s)	403	1501
Swelling/ Edema	308	318
Inadequate Osseointegration	306	308
Loss of Range of Motion	234	240
Fall	234	237
Discomfort	233	236
Synovitis	194	4269
Inflammation	179	180
Hypersensitivity/Allergic reaction	173	181
Implant Pain	166	167
Scar Tissue	165	190
Unspecified Tissue Injury	163	171
Ossification	96	4163
Physical Asymmetry	89	93
Muscle/Tendon Damage	89	93
Cyst(s)	83	85
Necrosis	79	4154
Bacterial Infection	69	70
Fluid Discharge	69	69
Hematoma	69	71
Distress	68	72
Unequal Limb Length	66	5725
Adhesion(s)	61	65
Nerve Damage	57	61
Fatigue	52	55
Hemorrhage/Bleeding	49	50
Impaired Healing	47	74
Thrombosis/Thrombus	45	53
Wound Dehiscence	42	45
Limb Fracture	41	42
Erythema	40	40
Post Operative Wound Infection	40	48
Fever	39	39
Osteopenia/ Osteoporosis	38	40
Sepsis	32	32
Hip Fracture	31	32
Deformity/ Disfigurement	30	8522
Unspecified Musculoskeletal problem	30	31