TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
BIOMECANICA INDUSTRIA E COMERCIODE PRODUTOS ORTOPEDICOS LTDA
	SUBSTANTIALLY EQUIVALENT	1
HERAEUS MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	3
ORMED GRUP MEDIKAL TURIZM SAGLIK HIZMETLERI SANAYI VE
	SUBSTANTIALLY EQUIVALENT	1
OSARTIS GMBH
	SUBSTANTIALLY EQUIVALENT	3
OSTEOREMEDIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
TECRES S.P.A.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	782	783
2022	472	474
2023	475	476
2024	492	493
2025	360	360
2026	71	71

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	813	813
Loss of or Failure to Bond	669	669
Chemical Problem	196	198
Loosening of Implant Not Related to Bone-Ingrowth	162	163
Migration or Expulsion of Device	83	83
Failure to Eject	80	80
Device Damaged Prior to Use	78	78
Patient Device Interaction Problem	69	69
Unsealed Device Packaging	66	66
Migration	51	51
Device Difficult to Setup or Prepare	46	46
Device Contaminated During Manufacture or Shipping	39	39
Missing Information	36	36
Tear, Rip or Hole in Device Packaging	34	34
Break	31	32
Insufficient Information	28	28
Fracture	25	25
Loss of Osseointegration	22	22
Expiration Date Error	22	22
Difficult to Open or Remove Packaging Material	21	22
Unstable	19	19
Fluid/Blood Leak	19	19
Improper Chemical Reaction	19	19
Improper or Incorrect Procedure or Method	17	17
Appropriate Term/Code Not Available	14	14
No Apparent Adverse Event	14	14
Osseointegration Problem	12	12
Off-Label Use	11	11
Loose or Intermittent Connection	10	10
Use of Device Problem	10	10
Shipping Damage or Problem	10	10
Device Handling Problem	9	9
Material Integrity Problem	8	8
Device Dislodged or Dislocated	8	8
Defective Device	7	7
Output Problem	7	7
Noise, Audible	6	6
Patient-Device Incompatibility	6	6
Coagulation in Device or Device Ingredient	6	6
Therapeutic or Diagnostic Output Failure	4	4
Device Ingredient or Reagent Problem	4	4
Premature Activation	4	4
Failure to Osseointegrate	4	4
Material Fragmentation	3	3
Biocompatibility	3	3
Unintended Movement	3	3
Contamination /Decontamination Problem	2	2
Component Missing	2	2
Improper Flow or Infusion	2	2
Device-Device Incompatibility	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	774	774
No Clinical Signs, Symptoms or Conditions	661	665
Insufficient Information	485	485
Swelling/ Edema	273	273
Joint Laxity	218	218
Unspecified Infection	215	215
Adhesion(s)	151	151
Loss of Range of Motion	134	134
Failure of Implant	121	122
Synovitis	107	107
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	105	105
Ambulation Difficulties	104	104
Muscular Rigidity	89	89
Fall	68	68
Discomfort	67	67
Unspecified Tissue Injury	62	62
Inadequate Osseointegration	45	45
Osteolysis	34	34
Pulmonary Embolism	31	31
Inflammation	30	30
Thrombosis/Thrombus	27	27
Implant Pain	26	26
Arthralgia	25	25
Muscle/Tendon Damage	25	25
Hemorrhage/Bleeding	22	22
Cardiac Arrest	21	21
Scar Tissue	21	21
Hematoma	20	20
Low Blood Pressure/ Hypotension	20	20
Necrosis	19	19
Bone Fracture(s)	19	19
Fluid Discharge	19	19
Cyst(s)	18	18
Hypersensitivity/Allergic reaction	16	16
Post Operative Wound Infection	16	16
Non-union Bone Fracture	14	14
Erythema	14	14
Wound Dehiscence	13	13
Fatigue	12	12
Nerve Damage	11	11
Joint Dislocation	10	10
Fibrosis	10	10
Arthritis	10	10
Perforation of Vessels	9	9
Sepsis	9	10
Impaired Healing	9	9
Deformity/ Disfigurement	8	8
Unspecified Musculoskeletal problem	7	7
Limb Fracture	7	7
Numbness	6	6

Recalls
Manufacturer		Recall Class	Date Posted
1	BIOPSYBELL S.R.L.	II	May-19-2021
2	Heraeus Medical GmbH (Dental Division)	II	Jan-14-2026
3	Howmedica Osteonics Corp.	III	Dec-20-2022
4	Smith & Nephew, Inc.	II	Jan-29-2021