TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, hip, semi-constrained, metal/polymer, cemented
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
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER ORTHOPAEDICS
	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	7046	7096
Device Dislodged or Dislocated	2992	2992
Insufficient Information	2246	2326
Naturally Worn	1976	1976
Fracture	835	855
Break	738	738
Degraded	594	594
Corroded	564	564
Loss of Osseointegration	455	455
Loosening of Implant Not Related to Bone-Ingrowth	431	434
Material Erosion	420	420
Detachment of Device or Device Component	369	373
Migration	348	354
Osseointegration Problem	331	331
Appropriate Term/Code Not Available	327	327
Unstable	307	307
Noise, Audible	215	215
Loss of or Failure to Bond	203	203
Biocompatibility	190	190
Difficult to Insert	185	185
Loose or Intermittent Connection	137	137
Packaging Problem	123	123
Nonstandard Device	120	120
Use of Device Problem	115	115
Malposition of Device	112	112
Material Deformation	99	99
Material Twisted/Bent	92	92
Device Contaminated During Manufacture or Shipping	90	90
Patient Device Interaction Problem	81	81
Unintended Movement	72	72
Positioning Failure	69	69
Connection Problem	67	67
Tear, Rip or Hole in Device Packaging	66	66
Device Markings/Labelling Problem	58	58
Material Disintegration	53	53
Mechanical Problem	48	50
Difficult to Remove	45	45
Incomplete or Inadequate Connection	42	42
Inadequacy of Device Shape and/or Size	38	38
Migration or Expulsion of Device	38	42
Crack	36	36
No Apparent Adverse Event	36	36
Off-Label Use	35	35
Material Fragmentation	34	34
Fitting Problem	33	33
Mechanical Jam	32	32
Failure to Osseointegrate	31	31
Defective Device	31	31
Device-Device Incompatibility	30	30
Physical Resistance/Sticking	27	27

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	5171	5171
Pain	4692	4692
Joint Dislocation	2698	2698
Unspecified Infection	2403	2412
Injury	1865	1865
Foreign Body Reaction	1565	1565
Failure of Implant	1314	1409
Test Result	1289	1289
No Clinical Signs, Symptoms or Conditions	1192	1192
Insufficient Information	1151	1151
Osteolysis	1003	1003
No Information	925	925
Bone Fracture(s)	873	887
Inflammation	862	862
Tissue Damage	765	765
Metal Related Pathology	756	756
Inadequate Osseointegration	732	732
Ambulation Difficulties	651	651
Reaction	568	568
Hypersensitivity/Allergic reaction	566	566
Discomfort	553	553
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	550	550
Joint Laxity	532	532
No Consequences Or Impact To Patient	526	526
No Known Impact Or Consequence To Patient	395	395
Limited Mobility Of The Implanted Joint	392	392
Loss of Range of Motion	365	365
Fall	307	307
Swelling/ Edema	276	276
Necrosis	248	248
Edema	225	225
No Patient Involvement	189	189
Adhesion(s)	181	181
Unspecified Tissue Injury	181	181
Synovitis	172	172
Ossification	166	166
Scar Tissue	156	175
Hematoma	149	149
Swelling	121	121
Hemorrhage/Bleeding	109	109
Joint Disorder	104	104
Implant Pain	102	102
Osteopenia/ Osteoporosis	99	99
Weakness	97	97
Hip Fracture	96	96
Fatigue	95	95
Physical Asymmetry	93	93
Host-Tissue Reaction	93	93
Cyst(s)	92	92
Distress	91	91