TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	3
G21 S.R.L
	SUBSTANTIALLY EQUIVALENT	2
G21 SRL
	SUBSTANTIALLY EQUIVALENT	1
OSARTIS GMBH
	SUBSTANTIALLY EQUIVALENT	1
TEKNIMED SAS
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	375	375
2021	649	649
2022	275	280
2023	262	262
2024	212	217
2025	152	152

Device Problems	MDRs with this Device Problem	Events in those MDRs
Loss of or Failure to Bond	819	822
Adverse Event Without Identified Device or Use Problem	429	429
Chemical Problem	176	176
Unsealed Device Packaging	122	122
Loosening of Implant Not Related to Bone-Ingrowth	77	82
Device Damaged Prior to Use	52	52
Improper Chemical Reaction	48	48
Device Contaminated During Manufacture or Shipping	45	45
Tear, Rip or Hole in Device Packaging	44	44
Patient Device Interaction Problem	43	43
Migration	32	32
Difficult to Open or Remove Packaging Material	20	20
Insufficient Information	13	13
Loss of Osseointegration	12	12
Expiration Date Error	11	11
Device Dislodged or Dislocated	11	11
Inaccurate Information	10	10
Device Ingredient or Reagent Problem	8	8
Off-Label Use	7	7
Fluid/Blood Leak	7	7
Patient-Device Incompatibility	7	7
Shipping Damage or Problem	7	7
Break	6	6
Improper or Incorrect Procedure or Method	6	6
Fracture	6	6
Biocompatibility	5	5
Material Integrity Problem	5	5
Coagulation in Device or Device Ingredient	5	5
Delivered as Unsterile Product	4	4
Osseointegration Problem	3	3
Output Problem	3	3
Appropriate Term/Code Not Available	3	3
Use of Device Problem	3	3
Powder Leak	2	2
Loose or Intermittent Connection	2	2
No Apparent Adverse Event	2	2
Product Quality Problem	2	2
Failure to Osseointegrate	2	2
Material Discolored	2	2
Contamination /Decontamination Problem	2	2
Physical Resistance/Sticking	2	4
Migration or Expulsion of Device	2	2
Fire	2	2
Device-Device Incompatibility	2	2
Packaging Problem	1	1
Device Handling Problem	1	1
Material Deformation	1	1
Infusion or Flow Problem	1	1
Partial Blockage	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	679	684
Insufficient Information	340	340
No Clinical Signs, Symptoms or Conditions	310	310
Adhesion(s)	196	196
No Code Available	180	180
Joint Laxity	173	173
Swelling/ Edema	161	166
Unspecified Infection	133	133
No Consequences Or Impact To Patient	110	110
Synovitis	99	99
Loss of Range of Motion	81	81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	78	78
Ambulation Difficulties	68	68
Failure of Implant	65	73
Muscular Rigidity	52	52
Discomfort	45	45
Edema	33	33
Fall	28	28
Inflammation	24	24
Limited Mobility Of The Implanted Joint	23	23
Inadequate Osseointegration	22	22
Scar Tissue	21	21
Arthralgia	20	20
Unspecified Tissue Injury	18	18
Low Blood Pressure/ Hypotension	17	17
Fatigue	15	15
Thrombosis/Thrombus	14	14
Cardiac Arrest	14	14
Hypersensitivity/Allergic reaction	14	14
Implant Pain	12	12
Osteolysis	11	11
Erythema	10	10
Wound Dehiscence	10	10
Joint Contracture	10	10
Foreign Body Reaction	10	10
Necrosis	9	9
Cyst(s)	9	9
Joint Dislocation	9	9
Embolism/Embolus	9	9
Local Reaction	9	9
No Patient Involvement	8	8
Bone Fracture(s)	8	8
Pulmonary Embolism	7	7
Injury	7	7
Unspecified Musculoskeletal problem	7	7
Bacterial Infection	7	7
Nerve Damage	6	9
Impaired Healing	6	6
Bradycardia	5	5
No Information	5	5

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