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	380	399
Break	114	114
Device Dislodged or Dislocated	61	66
Loosening of Implant Not Related to Bone-Ingrowth	48	53
Device-Device Incompatibility	39	39
Insufficient Information	26	31
Fracture	25	25
Naturally Worn	21	21
Detachment of Device or Device Component	19	19
Patient Device Interaction Problem	16	18
Material Deformation	16	16
Unstable	12	12
Osseointegration Problem	10	10
Difficult to Insert	10	10
Loss of or Failure to Bond	8	8
Migration	7	7
Material Erosion	5	5
Unintended Movement	5	5
Defective Device	4	4
Scratched Material	4	4
No Apparent Adverse Event	4	4
Noise, Audible	3	3
Positioning Failure	3	3
Loss of Osseointegration	2	2
Improper or Incorrect Procedure or Method	2	2
Inadequacy of Device Shape and/or Size	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
Shipping Damage or Problem	1	1
Material Fragmentation	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	156	156
Insufficient Information	133	146
Unspecified Tissue Injury	129	129
Pain	96	99
Failure of Implant	75	83
Joint Dislocation	48	53
Unspecified Infection	41	43
Joint Laxity	40	40
Bone Fracture(s)	40	41
Muscle/Tendon Damage	36	38
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
Inadequate Osseointegration	10	10
Fall	8	8
Osteolysis	8	10
Osteopenia/ Osteoporosis	8	8
Thrombosis/Thrombus	7	7
Inflammation	6	6
Synovitis	6	6
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
Impaired Healing	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Foreign Body In Patient	3	3
Wound Dehiscence	3	3
No Known Impact Or Consequence To Patient	2	2
Swelling/ Edema	2	3
Rheumatoid Arthritis	2	4
Foreign Body Reaction	1	1
Fever	1	2
Ossification	1	1
Purulent Discharge	1	1
Localized Skin Lesion	1	2
Nerve Damage	1	1
Numbness	1	1
Cyst(s)	1	1
No Code Available	1	1
Arthralgia	1	1
Non-union Bone Fracture	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