TPLC - Total Product Life Cycle

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Device	prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
Product Code	MAY
Regulation Number	888.3353
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	27	27
Break	9	9
Device Dislodged or Dislocated	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Device Contaminated During Manufacture or Shipping	5	5
Tear, Rip or Hole in Device Packaging	5	5
Naturally Worn	5	5
Unstable	4	4
Material Fragmentation	3	3
Noise, Audible	3	3
Migration	3	3
Material Deformation	2	2
Loss of or Failure to Bond	2	2
Packaging Problem	2	2
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Detachment of Device or Device Component	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Crack	1	1
Degraded	1	1
Difficult to Insert	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Unraveled Material	1	1
Material Too Soft/Flexible	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20	20
Failure of Implant	13	13
No Patient Involvement	11	11
Pain	8	8
Joint Dislocation	6	6
Bone Fracture(s)	6	6
Insufficient Information	6	6
No Known Impact Or Consequence To Patient	4	4
Osteopenia/ Osteoporosis	3	3
Unspecified Infection	3	3
Scar Tissue	2	2
No Information	2	2
Malunion of Bone	2	2
Unequal Limb Length	2	2
Swelling/ Edema	2	2
Metal Related Pathology	1	1
No Code Available	1	1
Local Reaction	1	1
Tissue Breakdown	1	1
Foreign Body In Patient	1	1
Sleep Dysfunction	1	1
Ambulation Difficulties	1	1
Blood Loss	1	1
Sepsis	1	1
Swelling	1	1
Tinnitus	1	1
Hypovolemia	1	1
Toxicity	1	1
Memory Loss/Impairment	1	1
Necrosis	1	1
Headache	1	1
Hearing Loss	1	1
Hypersensitivity/Allergic reaction	1	1
High Blood Pressure/ Hypertension	1	1
Arthritis	1	1
Atrial Fibrillation	1	1
Emotional Changes	1	1
Fall	1	1