TPLC - Total Product Life Cycle

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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	334	353
Break	111	111
Device Dislodged or Dislocated	53	58
Loosening of Implant Not Related to Bone-Ingrowth	48	53
Device-Device Incompatibility	36	36
Insufficient Information	26	31
Fracture	25	25
Naturally Worn	21	21
Detachment of Device or Device Component	18	18
Patient Device Interaction Problem	16	18
Material Deformation	16	16
Unstable	12	12
Loss of or Failure to Bond	8	8
Difficult to Insert	8	8
Osseointegration Problem	7	7
Migration	7	7
Material Erosion	5	5
Unintended Movement	5	5
Defective Device	4	4
Scratched Material	4	4
Noise, Audible	3	3
Positioning Failure	3	3
Loss of Osseointegration	2	2
Improper or Incorrect Procedure or Method	2	2
Material Separation	2	3
Failure to Cut	2	2
Use of Device Problem	2	2
Malposition of Device	2	2
Separation Problem	2	2
Delivered as Unsterile Product	1	1
Packaging Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Material Fragmentation	1	1
No Apparent Adverse Event	1	1
Degraded	1	1
Difficult to Remove	1	1
Failure to Advance	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Appropriate Term/Code Not Available	1	1
Patient-Device Incompatibility	1	1
Component Incompatible	1	1
Corroded	1	1
Loose or Intermittent Connection	1	1
Separation Failure	1	1
Mechanical Jam	1	1
Device Markings/Labelling Problem	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	147	147
Insufficient Information	117	130
Unspecified Tissue Injury	108	108
Pain	94	97
Failure of Implant	75	83
Joint Dislocation	45	50
Bone Fracture(s)	38	39
Joint Laxity	36	36
Unspecified Infection	33	35
Muscle/Tendon Damage	31	33
Loss of Range of Motion	25	27
Erosion	20	20
Subluxation	19	21
Hematoma	14	14
Metal Related Pathology	13	13
Fluid Discharge	12	12
Osteolysis	8	10
Osteopenia/ Osteoporosis	8	8
Inadequate Osseointegration	7	7
Thrombosis/Thrombus	7	7
Inflammation	6	6
Synovitis	6	6
Fall	5	5
Discomfort	5	7
Pulmonary Embolism	4	4
Arthritis	4	4
Scar Tissue	4	4
Muscular Rigidity	4	4
Implant Pain	4	4
Adhesion(s)	4	4
Limited Mobility Of The Implanted Joint	4	4
Hypersensitivity/Allergic reaction	4	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Impaired Healing	4	4
Foreign Body In Patient	3	3
Wound Dehiscence	3	3
No Known Impact Or Consequence To Patient	2	2
Rheumatoid Arthritis	2	4
Swelling/ Edema	2	3
Foreign Body Reaction	1	1
Fever	1	2
Ossification	1	1
Purulent Discharge	1	1
Localized Skin Lesion	1	2
Cyst(s)	1	1
Nerve Damage	1	1
Numbness	1	1
No Code Available	1	1
Arthralgia	1	1
Damage to Ligament(s)	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