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	448	467
Break	118	118
Device Dislodged or Dislocated	67	72
Loosening of Implant Not Related to Bone-Ingrowth	52	57
Device-Device Incompatibility	38	38
Fracture	28	28
Insufficient Device Problem Information	27	32
Naturally Worn	22	22
Detachment of Device or Device Component	19	19
Material Deformation	17	17
Osseointegration Problem	14	14
Patient Device Interaction Problem	14	16
Unstable	11	11
Difficult to Insert	11	11
Migration	10	10
Loss of or Failure to Bond	9	9
No Apparent Adverse Event	6	6
Unintended Movement	5	5
Material Erosion	5	5
Positioning Failure	4	4
Defective Device	4	4
Scratched Material	4	4
Use of Device Problem	3	3
Noise, Audible	3	3
Improper or Incorrect Procedure or Method	2	2
Inadequacy of Device Shape and/or Size	2	2
Failure to Cut	2	2
Malposition of Device	2	2
Separation Problem	2	2
Difficult to Remove	1	1
Off-Label Use	1	1
Delivered as Unsterile Product	1	1
Device Markings/Labelling Problem	1	1
Missing Information	1	1
Device Contaminated During Manufacture or Shipping	1	1
Degraded	1	1
Crack	1	1
Patient-Device Incompatibility	1	1
Mechanical Jam	1	1
Difficult or Delayed Separation	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Advance	1	1
Component Incompatible	1	1
Device Damaged Prior to Receipt by User	1	1
Material Separation	1	1
Implant subsidence	1	1
Tear, Rip or Hole in Device Packaging	1	1
Corroded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	171	171
Unspecified Tissue Injury	165	165
Insufficient Information	144	157
Pain	96	99
Failure of Implant	73	81
Joint Dislocation	51	56
Joint Laxity	48	48
Bone Fracture(s)	46	47
Unspecified Infection	45	47
Muscle/Tendon Damage	35	37
Loss of Range of Motion	26	28
Erosion	23	23
Subluxation	19	21
Metal Related Pathology	15	15
Inadequate Osseointegration	15	15
Hematoma	15	15
Fluid Discharge	12	12
Osteolysis	12	14
Thrombosis/Thrombus	8	8
Osteopenia/ Osteoporosis	8	8
Medical device site infection	7	9
Fall	7	7
Aseptic loosening	7	7
Inflammation	6	6
Synovitis	6	6
Periprosthetic fracture	6	6
Peripheral Nervous Injury	5	5
Hypersensitivity/Allergic reaction	5	6
Implant Pain	5	5
Discomfort	5	7
Scar Tissue	4	4
Arthropathy	4	4
Arthritis	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Impaired Healing	4	4
Muscular Rigidity	4	4
Adhesion(s)	4	4
Pulmonary Embolism	4	4
Wound Dehiscence	3	3
Foreign Body In Patient	3	3
Swelling/ Edema	3	4
Joint Impingement	3	3
Rheumatoid Arthritis	2	4
Nerve Damage	2	2
Foreign Body Reaction	2	2
Radiolucent Lines	2	2
Tissue Breakdown	1	1
Damage to Ligament(s)	1	1
Cyst(s)	1	1
Purulent Discharge	1	1

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