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TPLC
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show TPLC since
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Device
bone cement, antibiotic
Product Code
MBB
Regulation Number
888.3027
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOMET MANUFACTURING CORP.
SUBSTANTIALLY EQUIVALENT
1
BIOMET, INC.
SUBSTANTIALLY EQUIVALENT
7
G21 S.R.L
SUBSTANTIALLY EQUIVALENT
3
G21 SRL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
41
41
2015
20
20
2016
327
327
2017
288
288
2018
330
330
2019
497
497
2020
375
375
2021
648
648
2022
275
275
2023
258
258
2024
57
57
Device Problems
MDRs with this Device Problem
Events in those MDRs
Loss of or Failure to Bond
895
895
Unsealed Device Packaging
711
711
Adverse Event Without Identified Device or Use Problem
396
396
Infusion or Flow Problem
340
340
Chemical Problem
153
153
Improper Chemical Reaction
150
150
Insufficient Information
94
94
Loosening of Implant Not Related to Bone-Ingrowth
71
71
No Flow
53
53
Tear, Rip or Hole in Device Packaging
51
51
Appropriate Term/Code Not Available
45
45
Patient Device Interaction Problem
39
39
Device Contaminated During Manufacture or Shipping
33
33
Device Damaged Prior to Use
31
31
Migration
28
28
Difficult to Open or Remove Packaging Material
19
19
Device Packaging Compromised
19
19
Loss of Osseointegration
18
18
Device Dislodged or Dislocated
14
14
Material Integrity Problem
13
13
Failure To Adhere Or Bond
12
12
Migration or Expulsion of Device
11
11
Break
11
11
Packaging Problem
10
10
Leak/Splash
10
10
Inaccurate Information
10
10
Expiration Date Error
10
10
Device Operates Differently Than Expected
10
10
Device Ingredient or Reagent Problem
8
8
Loose or Intermittent Connection
8
8
Missing Value Reason
6
6
Improper Flow or Infusion
6
6
Off-Label Use
6
6
Fracture
6
6
Patient-Device Incompatibility
5
5
Clumping in Device or Device Ingredient
5
5
Use of Device Problem
5
5
Physical Property Issue
5
5
Incomplete or Missing Packaging
5
5
Device Handling Problem
4
4
Naturally Worn
4
4
Mechanical Problem
4
4
Biocompatibility
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Shipping Damage or Problem
4
4
Delivered as Unsterile Product
4
4
Material Discolored
4
4
Improper or Incorrect Procedure or Method
4
4
Contamination
4
4
Unstable
3
3
Fire
3
3
Coagulation in Device or Device Ingredient
3
3
No Apparent Adverse Event
3
3
Difficult to Open or Close
3
3
Fluid/Blood Leak
3
3
Output Problem
3
3
Physical Resistance/Sticking
3
3
Device-Device Incompatibility
2
2
Device Contamination with Chemical or Other Material
2
2
Device Emits Odor
2
2
Crack
2
2
Device Expiration Issue
2
2
Device Disinfection Or Sterilization Issue
2
2
Malposition of Device
2
2
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
2
2
Therapeutic or Diagnostic Output Failure
2
2
Contamination /Decontamination Problem
2
2
Precipitate in Device or Device Ingredient
2
2
Product Quality Problem
2
2
Osseointegration Problem
1
1
Defective Component
1
1
Missing Information
1
1
Failure to Osseointegrate
1
1
Activation Failure
1
1
Unintended System Motion
1
1
Difficult to Insert
1
1
Material Rupture
1
1
Material Too Soft/Flexible
1
1
Temperature Problem
1
1
Detachment of Device or Device Component
1
1
Overheating of Device
1
1
Microbial Contamination of Device
1
1
Torn Material
1
1
Noise, Audible
1
1
Shelf Life Exceeded
1
1
Device Slipped
1
1
Human Factors Issue
1
1
Powder Leak
1
1
Inadequate or Insufficient Training
1
1
Material Fragmentation
1
1
Contamination of Device Ingredient or Reagent
1
1
Sticking
1
1
Material Deformation
1
1
Detachment Of Device Component
1
1
Partial Blockage
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
936
936
Pain
732
732
No Code Available
333
333
Insufficient Information
274
274
No Clinical Signs, Symptoms or Conditions
245
245
Adhesion(s)
209
209
No Known Impact Or Consequence To Patient
203
203
Joint Laxity
170
170
No Information
169
169
Unspecified Infection
151
151
Swelling/ Edema
146
146
Synovitis
98
98
Loss of Range of Motion
92
92
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
79
79
No Patient Involvement
78
78
Failure of Implant
78
78
Ambulation Difficulties
63
63
Muscular Rigidity
62
62
Discomfort
58
58
Edema
52
52
Limited Mobility Of The Implanted Joint
42
42
Fall
33
33
Inflammation
30
30
Fatigue
21
21
Death
20
20
Cardiac Arrest
18
18
Scar Tissue
18
18
Injury
18
18
Arthralgia
17
17
Joint Disorder
17
17
Swelling
16
16
Weakness
15
15
Hypersensitivity/Allergic reaction
15
15
Not Applicable
15
15
Unspecified Tissue Injury
14
14
Cyst(s)
14
14
Low Blood Pressure/ Hypotension
14
14
Erythema
13
13
Thrombosis/Thrombus
13
13
Inadequate Osseointegration
13
13
Joint Contracture
12
12
Foreign Body Reaction
12
12
Wound Dehiscence
11
11
Necrosis
10
10
Implant Pain
10
10
Local Reaction
9
9
Pulmonary Embolism
8
8
Bone Fracture(s)
8
8
Fibrosis
7
7
Joint Dislocation
7
7
Osteolysis
7
7
Hemorrhage/Bleeding
6
6
Bacterial Infection
6
6
Scarring
6
6
Nerve Damage
6
6
Rash
5
5
Thrombosis
5
5
Impaired Healing
5
5
Reaction
5
5
Numbness
5
5
Embolism/Embolus
5
5
Muscle/Tendon Damage
5
5
Unspecified Musculoskeletal problem
4
4
Post Operative Wound Infection
4
4
Bradycardia
4
4
Arthritis
3
3
High Blood Pressure/ Hypertension
3
3
Ischemia
3
3
Low Oxygen Saturation
3
3
Missing Value Reason
3
3
Osteopenia/ Osteoporosis
3
3
Confusion/ Disorientation
2
2
Vomiting
2
2
Patient Problem/Medical Problem
2
2
Paresthesia
2
2
Sudden Cardiac Death
2
2
Deformity/ Disfigurement
2
2
Physical Asymmetry
2
2
Reaction to Medicinal Component of Device
2
2
Limb Fracture
2
2
Neurological Deficit/Dysfunction
2
2
Neuropathy
2
2
Myocardial Infarction
2
2
Nausea
2
2
Burning Sensation
2
2
Skin Discoloration
2
2
Hip Fracture
2
2
Discharge
2
2
Hematoma
2
2
Fever
2
2
Non specific EKG/ECG Changes
2
2
Cellulitis
2
2
Stroke/CVA
2
2
Erosion
2
2
Abscess
2
2
Ossification
1
1
Arrhythmia
1
1
Infarction, Cerebral
1
1
Cardiopulmonary Arrest
1
1
Fistula
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Mar-05-2015
2
DePuy Orthopaedics, Inc.
II
Oct-23-2013
3
Howmedica Osteonics Corp.
II
Nov-15-2022
4
Zimmer, Inc.
II
Jan-13-2014
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