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
1. K220216 C-Stem AMT LE Prosthesis
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	4993	5173
Device Dislodged or Dislocated	1920	1920
Naturally Worn	1495	1495
Insufficient Information	1065	1145
Fracture	600	620
Degraded	470	470
Break	468	468
Loosening of Implant Not Related to Bone-Ingrowth	421	424
Detachment of Device or Device Component	389	393
Material Erosion	370	370
Corroded	341	341
Appropriate Term/Code Not Available	213	213
Osseointegration Problem	209	209
Unstable	196	196
Migration	185	191
Difficult to Insert	156	156
Loss of Osseointegration	156	156
Noise, Audible	123	123
Loss of or Failure to Bond	98	98
Use of Device Problem	93	93
Material Twisted/Bent	91	91
Material Deformation	91	91
Device Contaminated During Manufacture or Shipping	82	82
Loose or Intermittent Connection	78	78
Packaging Problem	78	78
Malposition of Device	70	70
Patient Device Interaction Problem	70	70
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
Failure to Osseointegrate	25	25
Device-Device Incompatibility	24	24
Biocompatibility	23	23
Fitting Problem	22	22
Manufacturing, Packaging or Shipping Problem	21	21
No Apparent Adverse Event	20	20
Migration or Expulsion of Device	17	21
Separation Failure	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	2952	2952
Joint Dislocation	1774	1774
No Code Available	1743	1743
Insufficient Information	1410	1410
Unspecified Infection	1328	1337
Failure of Implant	1286	1457
No Clinical Signs, Symptoms or Conditions	1239	1239
Foreign Body Reaction	1070	1070
Osteolysis	853	853
Metal Related Pathology	752	752
Ambulation Difficulties	647	647
Joint Laxity	596	596
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	594	594
Bone Fracture(s)	528	542
Injury	450	450
Inflammation	425	425
Inadequate Osseointegration	393	393
Hypersensitivity/Allergic reaction	345	345
No Information	330	330
Test Result	306	306
Discomfort	298	298
Swelling/ Edema	293	293
Fall	277	277
Loss of Range of Motion	239	239
Reaction	211	211
Synovitis	186	186
No Known Impact Or Consequence To Patient	180	180
Unspecified Tissue Injury	171	171
No Consequences Or Impact To Patient	170	170
Scar Tissue	147	166
Adhesion(s)	146	146
Necrosis	143	143
Implant Pain	140	140
Edema	129	129
No Patient Involvement	122	122
Hematoma	110	110
Ossification	106	160
Limited Mobility Of The Implanted Joint	100	100
Physical Asymmetry	96	96
Tissue Damage	94	94
Cyst(s)	82	82
Distress	78	78
Hemorrhage/Bleeding	78	78
Hip Fracture	75	75
Fatigue	74	74
Muscle/Tendon Damage	69	69
Osteopenia/ Osteoporosis	68	68
Bacterial Infection	67	67
Fluid Discharge	66	66
Nerve Damage	66	66