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	309	309
Break	109	109
Device Dislodged or Dislocated	51	51
Loosening of Implant Not Related to Bone-Ingrowth	47	47
Device-Device Incompatibility	36	36
Insufficient Information	26	26
Fracture	25	25
Naturally Worn	21	21
Detachment of Device or Device Component	18	18
Patient Device Interaction Problem	16	16
Material Deformation	16	16
Unstable	10	10
Loss of or Failure to Bond	8	8
Osseointegration Problem	7	7
Migration	7	7
Difficult to Insert	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	2
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
Material Fragmentation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Degraded	1	1
No Apparent Adverse Event	1	1
Difficult to Remove	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Advance	1	1
Patient-Device Incompatibility	1	1
Appropriate Term/Code Not Available	1	1
Separation Failure	1	1
Component Incompatible	1	1
Corroded	1	1
Loose or Intermittent Connection	1	1
Device Markings/Labelling Problem	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	145	145
Insufficient Information	109	109
Unspecified Tissue Injury	97	97
Pain	91	91
Failure of Implant	73	73
Joint Dislocation	42	42
Bone Fracture(s)	38	38
Unspecified Infection	33	33
Joint Laxity	31	31
Muscle/Tendon Damage	31	31
Loss of Range of Motion	24	24
Erosion	20	20
Subluxation	19	19
Hematoma	14	14
Metal Related Pathology	13	13
Fluid Discharge	12	12
Osteopenia/ Osteoporosis	8	8
Osteolysis	8	8
Inadequate Osseointegration	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
Hypersensitivity/Allergic reaction	4	4
Limited Mobility Of The Implanted Joint	4	4
Adhesion(s)	4	4
Implant Pain	4	4
Scar Tissue	4	4
Muscular Rigidity	4	4
Wound Dehiscence	3	3
Foreign Body In Patient	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