TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	22	22
Break	14	14
Adverse Event Without Identified Device or Use Problem	8	9
Unstable	4	4
Device Dislodged or Dislocated	4	4
Naturally Worn	4	4
Material Deformation	3	3
Migration	3	3
Tear, Rip or Hole in Device Packaging	2	2
Loss of or Failure to Bond	2	2
Mechanical Problem	1	1
Off-Label Use	1	1
Physical Resistance/Sticking	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Device Fell	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Degraded	1	1
Difficult to Insert	1	1
Packaging Problem	1	1
Detachment of Device or Device Component	1	1
Appropriate Term/Code Not Available	1	1
Material Too Soft/Flexible	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24	24
Failure of Implant	13	13
Insufficient Information	8	9
Bone Fracture(s)	6	6
Pain	6	6
Joint Dislocation	3	3
Osteopenia/ Osteoporosis	3	3
Unspecified Infection	2	2
No Patient Involvement	2	2
Unequal Limb Length	2	2
Scar Tissue	2	2
Malunion of Bone	2	2
Swelling/ Edema	2	2
Metal Related Pathology	1	1
Electrolyte Imbalance	1	1
Post Operative Wound Infection	1	1
Foreign Body In Patient	1	1
Fall	1	1
Hemorrhage/Bleeding	1	1
Tissue Breakdown	1	1
Ambulation Difficulties	1	1