TPLC - Total Product Life Cycle

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Device	bone cement, antibiotic
Regulation Description	Polymethylmethacrylate (PMMA) bone cement.
Product Code	MBB
Regulation Number	888.3027
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Loss of or Failure to Bond	792	792
Adverse Event Without Identified Device or Use Problem	400	400
Chemical Problem	165	165
Unsealed Device Packaging	122	122
Loosening of Implant Not Related to Bone-Ingrowth	73	78
Improper Chemical Reaction	48	48
Patient Device Interaction Problem	43	43
Tear, Rip or Hole in Device Packaging	43	43
Device Damaged Prior to Use	42	42
Device Contaminated During Manufacture or Shipping	34	34
Migration	30	30
Difficult to Open or Remove Packaging Material	18	18
Insufficient Information	13	13
Device Dislodged or Dislocated	11	11
Loss of Osseointegration	10	10
Inaccurate Information	10	10
Expiration Date Error	10	10
Device Ingredient or Reagent Problem	8	8
Off-Label Use	7	7
Break	6	6
Biocompatibility	5	5
Improper or Incorrect Procedure or Method	5	5
Coagulation in Device or Device Ingredient	5	5
Material Integrity Problem	5	5
Fracture	5	5
Patient-Device Incompatibility	4	4
Fluid/Blood Leak	3	3
Osseointegration Problem	3	3
Appropriate Term/Code Not Available	3	3
Output Problem	3	3
Failure to Osseointegrate	2	2
Use of Device Problem	2	2
Delivered as Unsterile Product	2	2
Product Quality Problem	2	2
Material Discolored	2	2
No Apparent Adverse Event	2	2
Contamination /Decontamination Problem	2	2
Physical Resistance/Sticking	2	2
Migration or Expulsion of Device	2	2
Fire	2	2
Device-Device Incompatibility	2	2
Powder Leak	2	2
Infusion or Flow Problem	1	1
Material Deformation	1	1
Packaging Problem	1	1
Device Handling Problem	1	1
Partial Blockage	1	1
Detachment of Device or Device Component	1	1
Activation Failure	1	1
Material Fragmentation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	653	653
Insufficient Information	321	321
No Clinical Signs, Symptoms or Conditions	271	271
Adhesion(s)	194	194
No Code Available	180	180
Joint Laxity	169	169
Swelling/ Edema	154	154
Unspecified Infection	122	122
No Consequences Or Impact To Patient	110	110
Synovitis	94	94
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	78	78
Loss of Range of Motion	76	76
Failure of Implant	65	70
Ambulation Difficulties	64	64
Muscular Rigidity	45	45
Discomfort	45	45
Edema	33	33
Fall	28	28
Inflammation	24	24
Limited Mobility Of The Implanted Joint	23	23
Scar Tissue	21	21
Inadequate Osseointegration	20	20
Arthralgia	19	19
Unspecified Tissue Injury	17	17
Low Blood Pressure/ Hypotension	16	16
Fatigue	15	15
Hypersensitivity/Allergic reaction	14	14
Cardiac Arrest	14	14
Thrombosis/Thrombus	13	13
Osteolysis	11	11
Implant Pain	11	11
Wound Dehiscence	10	10
Joint Contracture	10	10
Local Reaction	9	9
Joint Dislocation	9	9
Embolism/Embolus	9	9
Cyst(s)	9	9
Necrosis	9	9
Foreign Body Reaction	8	8
No Patient Involvement	8	8
Erythema	8	8
Bone Fracture(s)	7	7
Injury	7	7
Bacterial Infection	7	7
Impaired Healing	6	6
Nerve Damage	6	6
Pulmonary Embolism	6	6
No Information	5	5
Bradycardia	5	5
Weakness	5	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Howmedica Osteonics Corp.	II	Nov-15-2022