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	382	401
Break	114	114
Device Dislodged or Dislocated	61	66
Loosening of Implant Not Related to Bone-Ingrowth	45	50
Device-Device Incompatibility	38	38
Insufficient Information	26	31
Fracture	24	24
Naturally Worn	21	21
Detachment of Device or Device Component	19	19
Material Deformation	16	16
Patient Device Interaction Problem	14	16
Unstable	12	12
Osseointegration Problem	10	10
Difficult to Insert	10	10
Loss of or Failure to Bond	8	8
Migration	7	7
Unintended Movement	5	5
Material Erosion	5	5
Scratched Material	4	4
Defective Device	4	4
No Apparent Adverse Event	4	4
Positioning Failure	3	3
Malposition of Device	3	3
Noise, Audible	3	3
Use of Device Problem	2	2
Failure to Cut	2	2
Material Separation	2	3
Inadequacy of Device Shape and/or Size	2	2
Improper or Incorrect Procedure or Method	2	2
Separation Problem	2	2
Degraded	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Shipping Damage or Problem	1	1
Delivered as Unsterile Product	1	1
Tear, Rip or Hole in Device Packaging	1	1
Patient-Device Incompatibility	1	1
Missing Information	1	1
Device Markings/Labelling Problem	1	1
Failure to Advance	1	1
Appropriate Term/Code Not Available	1	1
Off-Label Use	1	1
Component Incompatible	1	1
Corroded	1	1
Loose or Intermittent Connection	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
No Clinical Signs, Symptoms or Conditions	158	158
Unspecified Tissue Injury	136	136
Insufficient Information	130	143
Pain	90	93
Failure of Implant	73	81
Joint Dislocation	48	53
Unspecified Infection	43	45
Joint Laxity	41	41
Bone Fracture(s)	38	39
Muscle/Tendon Damage	34	36
Loss of Range of Motion	22	24
Erosion	20	20
Subluxation	19	21
Metal Related Pathology	13	13
Hematoma	13	13
Fluid Discharge	12	12
Inadequate Osseointegration	10	10
Osteopenia/ Osteoporosis	8	8
Fall	7	7
Osteolysis	7	9
Thrombosis/Thrombus	7	7
Synovitis	6	6
Inflammation	6	6
Discomfort	5	7
Implant Pain	4	4
Muscular Rigidity	4	4
Adhesion(s)	4	4
Scar Tissue	4	4
Hypersensitivity/Allergic reaction	4	5
Impaired Healing	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Arthritis	4	4
Pulmonary Embolism	4	4
Foreign Body In Patient	3	3
Wound Dehiscence	3	3
Foreign Body Reaction	2	2
Rheumatoid Arthritis	2	4
Swelling/ Edema	2	3
Purulent Discharge	1	1
Localized Skin Lesion	1	2
No Known Impact Or Consequence To Patient	1	1
Fever	1	2
Nerve Damage	1	1
Numbness	1	1
Cyst(s)	1	1
Arthralgia	1	1
Damage to Ligament(s)	1	1
Bacterial Infection	1	1
Tissue Breakdown	1	1
Ambulation Difficulties	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