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
1. K213701 Exeter® X3® RimFit® Cup
2. K222056 Global Modular Replacement System, Modular Replace ...
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
1. K213701 Exeter® X3® RimFit® Cup
2. K222056 Global Modular Replacement System, Modular Replace ...
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	4906	4956
Device Dislodged or Dislocated	1893	1893
Naturally Worn	1458	1458
Insufficient Information	1042	1122
Fracture	574	594
Break	468	468
Degraded	457	457
Loosening of Implant Not Related to Bone-Ingrowth	411	414
Detachment of Device or Device Component	375	379
Material Erosion	361	361
Corroded	332	332
Appropriate Term/Code Not Available	213	213
Osseointegration Problem	200	200
Unstable	195	195
Migration	182	188
Loss of Osseointegration	152	152
Difficult to Insert	149	149
Noise, Audible	121	121
Loss of or Failure to Bond	98	98
Use of Device Problem	92	92
Material Deformation	91	91
Material Twisted/Bent	89	89
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	56	56
Unintended Movement	49	49
Mechanical Problem	46	48
Incomplete or Inadequate Connection	42	42
Tear, Rip or Hole in Device Packaging	35	35
Difficult to Remove	33	33
Off-Label Use	32	32
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	24	24
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
Material Integrity Problem	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	2901	2901
Joint Dislocation	1747	1747
No Code Available	1743	1743
Insufficient Information	1357	1357
Unspecified Infection	1306	1315
Failure of Implant	1275	1370
No Clinical Signs, Symptoms or Conditions	1215	1215
Foreign Body Reaction	1057	1057
Osteolysis	825	825
Metal Related Pathology	727	727
Ambulation Difficulties	634	634
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	590	590
Joint Laxity	583	583
Bone Fracture(s)	509	523
Injury	450	450
Inflammation	427	427
Inadequate Osseointegration	382	382
Hypersensitivity/Allergic reaction	346	346
No Information	330	330
Test Result	306	306
Discomfort	292	292
Swelling/ Edema	291	291
Fall	275	275
Loss of Range of Motion	227	227
Reaction	211	211
No Known Impact Or Consequence To Patient	180	180
Synovitis	178	178
Unspecified Tissue Injury	171	171
No Consequences Or Impact To Patient	170	170
Adhesion(s)	146	146
Necrosis	144	144
Scar Tissue	136	155
Implant Pain	132	132
Edema	129	129
No Patient Involvement	122	122
Hematoma	109	109
Ossification	104	104
Limited Mobility Of The Implanted Joint	100	100
Physical Asymmetry	95	95
Tissue Damage	94	94
Distress	80	80
Cyst(s)	80	80
Hemorrhage/Bleeding	78	78
Fatigue	76	76
Hip Fracture	72	72
Osteopenia/ Osteoporosis	68	68
Muscle/Tendon Damage	67	67
Bacterial Infection	67	67
Nerve Damage	65	65
Fluid Discharge	64	64