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
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
MICROPORT ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	2
ONKOS SURGICAL
	SUBSTANTIALLY EQUIVALENT	3
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER INC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4946	5126
Device Dislodged or Dislocated	1904	1904
Naturally Worn	1484	1484
Insufficient Information	1051	1131
Fracture	587	607
Break	468	468
Degraded	465	465
Loosening of Implant Not Related to Bone-Ingrowth	415	418
Detachment of Device or Device Component	383	387
Material Erosion	364	364
Corroded	339	339
Appropriate Term/Code Not Available	213	213
Osseointegration Problem	207	207
Unstable	196	196
Migration	184	190
Difficult to Insert	156	156
Loss of Osseointegration	152	152
Noise, Audible	122	122
Loss of or Failure to Bond	98	98
Use of Device Problem	93	93
Material Deformation	91	91
Material Twisted/Bent	90	90
Device Contaminated During Manufacture or Shipping	82	82
Loose or Intermittent Connection	78	78
Packaging Problem	78	78
Patient Device Interaction Problem	70	70
Malposition of Device	69	69
Connection Problem	65	65
Positioning Failure	58	58
Mechanical Problem	50	52
Unintended Movement	49	49
Incomplete or Inadequate Connection	42	42
Tear, Rip or Hole in Device Packaging	36	36
Off-Label Use	33	33
Difficult to Remove	33	33
Mechanical Jam	28	28
Crack	27	27
Defective Device	27	27
Material Fragmentation	27	27
Physical Resistance/Sticking	26	26
Device Appears to Trigger Rejection	26	26
Inadequacy of Device Shape and/or Size	25	25
Device-Device Incompatibility	24	24
Failure to Osseointegrate	23	23
Biocompatibility	23	23
Fitting Problem	22	22
Manufacturing, Packaging or Shipping Problem	21	21
No Apparent Adverse Event	20	20
Premature Separation	17	17
Positioning Problem	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	2928	2928
Joint Dislocation	1760	1760
No Code Available	1743	1743
Insufficient Information	1378	1378
Unspecified Infection	1316	1325
Failure of Implant	1282	1453
No Clinical Signs, Symptoms or Conditions	1234	1234
Foreign Body Reaction	1061	1061
Osteolysis	838	838
Metal Related Pathology	740	740
Ambulation Difficulties	642	642
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	593	593
Joint Laxity	590	590
Bone Fracture(s)	520	534
Injury	450	450
Inflammation	425	425
Inadequate Osseointegration	388	388
Hypersensitivity/Allergic reaction	344	344
No Information	330	330
Test Result	306	306
Discomfort	295	295
Swelling/ Edema	292	292
Fall	276	276
Loss of Range of Motion	236	236
Reaction	211	211
Synovitis	184	184
No Known Impact Or Consequence To Patient	180	180
Unspecified Tissue Injury	170	170
No Consequences Or Impact To Patient	170	170
Adhesion(s)	146	146
Necrosis	143	143
Scar Tissue	142	161
Implant Pain	138	138
Edema	129	129
No Patient Involvement	122	122
Hematoma	110	110
Ossification	105	159
Limited Mobility Of The Implanted Joint	100	100
Physical Asymmetry	95	95
Tissue Damage	94	94
Cyst(s)	80	80
Distress	78	78
Hemorrhage/Bleeding	78	78
Fatigue	74	74
Hip Fracture	74	74
Osteopenia/ Osteoporosis	68	68
Muscle/Tendon Damage	68	68
Bacterial Infection	67	67
Nerve Damage	65	65
Fluid Discharge	64	64