TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
Regulation Description	Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
Product Code	MBF
Regulation Number	888.3670
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	249	249
Break	107	107
Loosening of Implant Not Related to Bone-Ingrowth	46	46
Device Dislodged or Dislocated	40	40
Device-Device Incompatibility	32	32
Insufficient Information	24	24
Fracture	21	21
Naturally Worn	20	20
Detachment of Device or Device Component	17	17
Material Deformation	15	15
Patient Device Interaction Problem	12	12
Unstable	9	9
Loss of or Failure to Bond	7	7
Migration	6	6
Material Erosion	5	5
Difficult to Insert	5	5
Osseointegration Problem	4	4
Defective Device	4	4
Scratched Material	4	4
Noise, Audible	3	3
Appropriate Term/Code Not Available	3	3
Unintended Movement	3	3
Failure to Cut	2	2
Material Separation	2	2
Loose or Intermittent Connection	2	2
Improper or Incorrect Procedure or Method	2	2
Malposition of Device	2	2
Loss of Osseointegration	2	2
Positioning Failure	1	1
Material Fragmentation	1	1
Delivered as Unsterile Product	1	1
Difficult to Remove	1	1
Packaging Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Material Integrity Problem	1	1
No Apparent Adverse Event	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Advance	1	1
Patient-Device Incompatibility	1	1
Separation Failure	1	1
Device Markings/Labelling Problem	1	1
Component Incompatible	1	1
Corroded	1	1
Mechanical Jam	1	1
Off-Label Use	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	135	135
Insufficient Information	95	95
Pain	88	88
Failure of Implant	72	72
Unspecified Tissue Injury	62	62
Joint Dislocation	33	33
Bone Fracture(s)	33	33
Muscle/Tendon Damage	26	26
Unspecified Infection	25	25
Loss of Range of Motion	24	24
Joint Laxity	22	22
Subluxation	19	19
Erosion	18	18
Hematoma	13	13
Metal Related Pathology	12	12
Fluid Discharge	12	12
Osteolysis	8	8
Osteopenia/ Osteoporosis	7	7
Thrombosis/Thrombus	7	7
Inflammation	6	6
Synovitis	6	6
Fall	5	5
Discomfort	5	5
Pulmonary Embolism	4	4
Arthritis	4	4
Impaired Healing	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Inadequate Osseointegration	4	4
Limited Mobility Of The Implanted Joint	4	4
Adhesion(s)	4	4
Implant Pain	4	4
Scar Tissue	4	4
Foreign Body In Patient	4	4
Muscular Rigidity	4	4
Wound Dehiscence	3	3
Hypersensitivity/Allergic reaction	3	3
Swelling/ Edema	2	2
No Known Impact Or Consequence To Patient	2	2
Rheumatoid Arthritis	2	2
Numbness	1	1
Nerve Damage	1	1
Fever	1	1
Foreign Body Reaction	1	1
Ossification	1	1
Localized Skin Lesion	1	1
Purulent Discharge	1	1
Non-union Bone Fracture	1	1
Cyst(s)	1	1
No Code Available	1	1
Arthralgia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Feb-24-2022
2	Biomet, Inc.	II	Mar-03-2020
3	Limacorporate S.p.A	II	Jan-12-2024
4	Limacorporate S.p.A	II	Jun-27-2023
5	Limacorporate S.p.A	II	Apr-01-2023
6	ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY	II	Mar-20-2025