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	675	679
Adverse Event Without Identified Device or Use Problem	390	391
Chemical Problem	193	195
Loosening of Implant Not Related to Bone-Ingrowth	56	64
Device Damaged Prior to Use	51	51
Device Contaminated During Manufacture or Shipping	45	45
Unsealed Device Packaging	45	45
Tear, Rip or Hole in Device Packaging	41	41
Improper Chemical Reaction	36	37
Patient Device Interaction Problem	34	34
Migration	30	30
Shipping Damage or Problem	21	21
Difficult to Open or Remove Packaging Material	20	20
Expiration Date Error	11	12
Inaccurate Information	10	10
Device Ingredient or Reagent Problem	8	8
Loss of Osseointegration	8	8
Off-Label Use	7	7
Insufficient Information	7	7
Device Dislodged or Dislocated	7	7
Fluid/Blood Leak	6	6
Patient-Device Incompatibility	6	6
Improper or Incorrect Procedure or Method	6	6
Fracture	6	7
Biocompatibility	5	5
Material Integrity Problem	5	5
Coagulation in Device or Device Ingredient	5	5
Device Markings/Labelling Problem	4	4
No Apparent Adverse Event	4	4
Output Problem	3	3
Osseointegration Problem	3	3
Physical Resistance/Sticking	3	5
Use of Device Problem	3	3
Powder Leak	2	2
Noise, Audible	2	2
Loose or Intermittent Connection	2	2
Appropriate Term/Code Not Available	2	2
Product Quality Problem	2	2
Delivered as Unsterile Product	2	2
Failure to Osseointegrate	2	2
Material Discolored	2	2
Material Fragmentation	2	2
Migration or Expulsion of Device	2	2
Fire	2	2
Break	2	2
Partial Blockage	1	1
Detachment of Device or Device Component	1	1
Device Handling Problem	1	1
Activation Failure	1	1
Packaging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	539	549
No Clinical Signs, Symptoms or Conditions	361	364
Insufficient Information	352	352
Adhesion(s)	165	165
Joint Laxity	162	163
Swelling/ Edema	153	160
Unspecified Infection	126	126
Synovitis	90	90
Loss of Range of Motion	80	80
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	73	73
Ambulation Difficulties	54	57
Failure of Implant	49	61
Muscular Rigidity	38	38
Discomfort	27	28
Fall	25	25
Scar Tissue	21	21
Unspecified Tissue Injury	20	20
Inadequate Osseointegration	19	19
Inflammation	17	17
Low Blood Pressure/ Hypotension	16	16
Cardiac Arrest	14	14
Implant Pain	13	13
Osteolysis	13	15
Arthralgia	11	11
Hypersensitivity/Allergic reaction	11	11
Thrombosis/Thrombus	11	11
Foreign Body Reaction	10	10
Wound Dehiscence	10	10
Necrosis	9	9
Bone Fracture(s)	9	10
Embolism/Embolus	9	9
Joint Contracture	8	8
Fatigue	8	8
Joint Dislocation	8	8
Pulmonary Embolism	8	8
Unspecified Musculoskeletal problem	7	7
Cyst(s)	6	6
Nerve Damage	6	9
Ossification	5	5
No Patient Involvement	5	5
Bacterial Infection	4	4
No Consequences Or Impact To Patient	4	4
Bradycardia	4	4
Hemorrhage/Bleeding	3	3
Fibrosis	3	3
Arthritis	3	3
Numbness	3	3
Cardiogenic Shock	3	3
Low Oxygen Saturation	3	3
Impaired Healing	3	3

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