TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal
Product Code	JDH
Regulation Number	888.3380
Device Class	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	337	337
Adverse Event Without Identified Device or Use Problem	273	273
Device Dislodged or Dislocated	101	101
Break	80	80
Fracture	66	66
Loosening of Implant Not Related to Bone-Ingrowth	50	50
Naturally Worn	41	41
Loose or Intermittent Connection	38	38
Biocompatibility	20	20
Unintended Movement	20	20
Appropriate Term/Code Not Available	16	16
Unstable	15	15
Degraded	11	11
Corroded	10	10
Material Deformation	9	9
Patient Device Interaction Problem	7	7
Compatibility Problem	7	7
Loss of Osseointegration	6	6
Material Integrity Problem	5	5
Migration or Expulsion of Device	5	5
Connection Problem	4	4
Malposition of Device	4	4
Material Separation	4	4
Migration	4	4
Crack	3	3
Incomplete or Inadequate Connection	3	3
Noise, Audible	3	3
Mechanical Jam	3	3
Activation, Positioning or Separation Problem	3	3
Device Damaged by Another Device	3	3
Mechanical Problem	3	3
Misassembled	3	3
Pitted	3	3
Metal Shedding Debris	3	3
Material Erosion	2	2
Separation Failure	2	2
Contamination /Decontamination Problem	2	2
Osseointegration Problem	2	2
Fitting Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Dull, Blunt	1	1
Loss of or Failure to Bond	1	1
Illegible Information	1	1
Device Contamination with Chemical or Other Material	1	1
Detachment of Device or Device Component	1	1
Device Handling Problem	1	1
Material Rupture	1	1
Failure to Osseointegrate	1	1
Material Twisted/Bent	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Injury	502	502
Unspecified Infection	129	129
No Clinical Signs, Symptoms or Conditions	95	95
Joint Dislocation	93	93
Pain	82	82
Bone Fracture(s)	76	76
Failure of Implant	68	68
Metal Related Pathology	40	40
No Known Impact Or Consequence To Patient	34	34
No Consequences Or Impact To Patient	32	32
No Information	29	29
Hip Fracture	18	18
Osteolysis	15	15
Inadequate Osseointegration	12	12
Thrombosis/Thrombus	10	10
Insufficient Information	10	10
Ambulation Difficulties	9	9
No Code Available	8	8
Test Result	8	8
Necrosis	7	7
Loss of Range of Motion	7	7
Inflammation	5	5
Implant Pain	5	5
Discomfort	5	5
Swelling/ Edema	4	4
Joint Laxity	4	4
Subluxation	4	4
Neuralgia	3	3
Foreign Body In Patient	3	3
Unequal Limb Length	3	3
Thrombosis	3	3
Tissue Breakdown	2	2
Hemorrhage/Bleeding	2	2
Non-union Bone Fracture	2	2
Toxicity	2	2
Muscular Rigidity	2	2
Post Operative Wound Infection	2	2
Ossification	2	2
Joint Disorder	2	2
Arthralgia	2	2
Death	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Swelling	1	1
No Patient Involvement	1	1
Ventricular Fibrillation	1	1
Hernia	1	1
Chest Pain	1	1
Scar Tissue	1	1
Laceration(s)	1	1
Fall	1	1