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	459	478
Break	119	119
Device Dislodged or Dislocated	72	77
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
Material Erosion	5	5
Unintended Movement	5	5
Defective Device	4	4
Scratched Material	4	4
Positioning Failure	4	4
Noise, Audible	3	3
Inadequacy of Device Shape and/or Size	3	3
Use of Device Problem	3	3
Malposition of Device	3	3
Failure to Cut	2	2
Separation Failure	2	2
Improper or Incorrect Procedure or Method	2	2
Off-Label Use	2	2
Separation Problem	2	2
Degraded	1	1
Delivered as Unsterile Product	1	1
Difficult or Delayed Separation	1	1
Difficult to Remove	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Patient-Device Incompatibility	1	1
Material Separation	1	1
Device Damaged Prior to Receipt by User	1	1
Tear, Rip or Hole in Device Packaging	1	1
Missing Information	1	1
Device Markings/Labelling Problem	1	1
Crack	1	1
Failure to Advance	1	1
Component Incompatible	1	1
Corroded	1	1
Mechanical Jam	1	1
Device Contaminated During Manufacture or Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Tissue Injury	173	173
No Clinical Signs, Symptoms or Conditions	173	173
Insufficient Information	138	151
Pain	100	103
Failure of Implant	73	81
Joint Dislocation	54	59
Joint Laxity	50	50
Bone Fracture(s)	47	48
Unspecified Infection	45	47
Muscle/Tendon Damage	36	38
Loss of Range of Motion	26	28
Erosion	23	23
Subluxation	19	21
Inadequate Osseointegration	15	15
Metal Related Pathology	15	15
Hematoma	15	15
Fluid Discharge	12	12
Osteolysis	12	14
Medical device site infection	10	12
Aseptic loosening	8	8
Osteopenia/ Osteoporosis	8	8
Thrombosis/Thrombus	8	8
Fall	7	7
Periprosthetic fracture	6	6
Inflammation	6	6
Synovitis	6	6
Peripheral Nervous Injury	5	5
Discomfort	5	7
Implant Pain	5	5
Hypersensitivity/Allergic reaction	5	6
Muscular Rigidity	4	4
Adhesion(s)	4	4
Scar Tissue	4	4
Arthropathy	4	4
Swelling/ Edema	4	5
Impaired Healing	4	4
Arthritis	4	4
Pulmonary Embolism	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Foreign Body In Patient	3	3
Wound Dehiscence	3	3
Joint Impingement	3	3
Foreign Body Reaction	2	2
Radiolucent Lines	2	2
Nerve Damage	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Rheumatoid Arthritis	2	4
No Known Impact Or Consequence To Patient	1	1
Fever	1	2
Osteomyelitis	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