TPLC - Total Product Life Cycle

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Device	prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained
Regulation Description	Wrist joint metal/polymer semi-constrained cemented prosthesis.
Product Code	JWJ
Regulation Number	888.3800
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	68	70
Migration	29	29
Loosening of Implant Not Related to Bone-Ingrowth	27	27
Loss of Osseointegration	19	19
Naturally Worn	6	6
Osseointegration Problem	6	6
Fracture	5	5
Device Dislodged or Dislocated	5	5
Break	2	2
Patient-Device Incompatibility	2	2
Degraded	2	2
Failure to Osseointegrate	2	2
Biocompatibility	2	2
Device Contaminated During Manufacture or Shipping	1	1
Unintended Movement	1	1
Expiration Date Error	1	1
Material Integrity Problem	1	1
Material Fragmentation	1	1
Material Deformation	1	1
Device Handling Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Nonstandard Device	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	48	48
Insufficient Information	26	26
Implant Pain	14	14
Osteolysis	14	14
Loss of Range of Motion	12	12
Pain	12	12
Unspecified Infection	8	10
Inadequate Osseointegration	8	8
Bone Fracture(s)	7	7
Arthralgia	4	4
No Clinical Signs, Symptoms or Conditions	4	4
Inflammation	4	4
Synovitis	4	4
Post Operative Wound Infection	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Osteopenia/ Osteoporosis	3	3
Joint Dislocation	2	2
Metal Related Pathology	2	2
Swelling/ Edema	2	2
Bacterial Infection	2	2
Rheumatoid Arthritis	1	1
Pneumothorax	1	1
Solid Tumour	1	1
Necrosis	1	1
Hematoma	1	1
No Known Impact Or Consequence To Patient	1	1
Fever	1	1
Nerve Damage	1	1
Discomfort	1	1
Malunion of Bone	1	1
Muscle/Tendon Damage	1	1
Joint Laxity	1	1
Infiltration into Tissue	1	1
Arthritis	1	1
Pulmonary Embolism	1	1
Fistula	1	1