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TPLC
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Device
prosthesis, shoulder, semi-constrained, metal/polymer cemented
Product Code
KWS
Regulation Number
888.3660
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARTHREX INC.
SUBSTANTIALLY EQUIVALENT
4
BIOMET INC.
SUBSTANTIALLY EQUIVALENT
1
CATALYST ORTHOSCIENCE, INC.
SUBSTANTIALLY EQUIVALENT
1
DEPUY LNC.
SUBSTANTIALLY EQUIVALENT
1
ENCORE MEDICAL, L.P.
SUBSTANTIALLY EQUIVALENT
3
EXACTECH, INC.
SUBSTANTIALLY EQUIVALENT
1
LIMACORPORATE
SUBSTANTIALLY EQUIVALENT
1
LIMACORPORATE S.P.A.
SUBSTANTIALLY EQUIVALENT
1
MATERIALISE NV
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
2
STRYKER GMBH
SUBSTANTIALLY EQUIVALENT
4
TECHMAH MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
TORNIER SAS
SUBSTANTIALLY EQUIVALENT
2
TORNIER, INC.
SUBSTANTIALLY EQUIVALENT
2
ZIMMER INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
1532
1532
2019
1726
1726
2020
1567
1567
2021
1364
1364
2022
1298
1398
2023
617
617
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2516
2547
Device Dislodged or Dislocated
1274
1317
Appropriate Term/Code Not Available
835
835
Fracture
747
762
Insufficient Information
588
588
Loosening of Implant Not Related to Bone-Ingrowth
401
403
Break
348
359
Detachment of Device or Device Component
284
284
Unstable
278
310
Loose or Intermittent Connection
238
238
Loss of Osseointegration
200
200
Naturally Worn
180
180
Migration
175
188
Difficult to Insert
131
131
Migration or Expulsion of Device
85
85
Osseointegration Problem
84
84
Loss of or Failure to Bond
81
81
Unintended Movement
73
73
Malposition of Device
63
63
Patient Device Interaction Problem
52
52
Noise, Audible
45
45
Inadequacy of Device Shape and/or Size
44
44
Positioning Failure
40
40
Material Fragmentation
34
34
Material Erosion
32
32
Therapeutic or Diagnostic Output Failure
29
29
Positioning Problem
28
28
Material Separation
27
27
Use of Device Problem
26
26
Device Slipped
25
25
Device-Device Incompatibility
25
25
Material Twisted/Bent
24
24
Device Contaminated During Manufacture or Shipping
23
23
Difficult to Remove
23
23
Mechanical Jam
22
22
Device Operates Differently Than Expected
21
21
Material Integrity Problem
20
20
Device Difficult to Setup or Prepare
20
20
Component Missing
18
18
Patient-Device Incompatibility
16
16
Degraded
15
15
Inaccurate Information
15
15
Material Deformation
14
14
Disassembly
14
14
Detachment Of Device Component
14
14
Mechanical Problem
14
14
Unintended System Motion
13
13
Crack
13
13
No Apparent Adverse Event
13
13
Packaging Problem
12
12
Failure to Osseointegrate
12
12
Failure to Align
11
11
Dull, Blunt
11
11
Defective Device
10
10
Microbial Contamination of Device
10
10
Disconnection
10
10
Corroded
10
10
Scratched Material
9
9
Material Split, Cut or Torn
9
9
Improper or Incorrect Procedure or Method
8
8
Fitting Problem
8
8
Off-Label Use
8
8
Difficult To Position
8
8
Physical Resistance/Sticking
7
7
Separation Problem
6
6
Output Problem
6
6
Contamination /Decontamination Problem
6
6
Delivered as Unsterile Product
6
6
Tear, Rip or Hole in Device Packaging
6
6
Entrapment of Device
6
6
Unsealed Device Packaging
5
5
Difficult or Delayed Positioning
5
5
Failure To Adhere Or Bond
5
5
Device Issue
5
5
Defective Component
5
5
Device Damaged by Another Device
5
5
Difficult to Advance
4
4
Connection Problem
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Biocompatibility
4
4
Material Rupture
4
4
Device Appears to Trigger Rejection
4
4
Contamination
4
4
Material Disintegration
4
4
Bent
3
3
Misassembled
3
3
Problem with Sterilization
3
3
Metal Shedding Debris
3
3
Human-Device Interface Problem
3
3
Installation-Related Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Device Packaging Compromised
2
2
Mechanics Altered
2
2
Device Fell
2
2
Ejection Problem
2
2
Device Handling Problem
2
2
Failure to Advance
2
2
Unexpected Therapeutic Results
2
2
Device Inoperable
2
2
Material Invagination
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
1341
1360
Pain
1316
1316
No Code Available
1224
1224
Joint Dislocation
914
929
Failure of Implant
722
729
No Clinical Signs, Symptoms or Conditions
536
536
Insufficient Information
527
574
No Information
380
380
No Known Impact Or Consequence To Patient
342
342
Bone Fracture(s)
326
326
Loss of Range of Motion
318
323
Patient Problem/Medical Problem
305
305
Not Applicable
253
253
Inadequate Osseointegration
211
211
Implant Pain
203
209
Fall
193
193
Joint Laxity
184
185
Injury
184
184
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
180
180
No Consequences Or Impact To Patient
158
158
Osteolysis
127
127
Limited Mobility Of The Implanted Joint
115
115
Bacterial Infection
106
106
Hematoma
99
99
Tissue Damage
97
97
Discomfort
90
90
Erosion
78
78
Foreign Body In Patient
70
70
Swelling
60
60
Muscle Weakness
55
55
Muscular Rigidity
50
50
Joint Disorder
50
50
Muscle/Tendon Damage
45
45
Ambulation Difficulties
44
44
Ossification
43
43
Metal Related Pathology
40
40
Reaction
39
39
Numbness
39
39
Inflammation
34
34
Osteopenia/ Osteoporosis
32
32
Rash
29
29
Arthritis
27
27
Foreign Body Reaction
27
27
Unspecified Tissue Injury
26
26
Nerve Damage
25
25
Tingling
25
25
Device Embedded In Tissue or Plaque
24
24
Post Operative Wound Infection
23
23
Fluid Discharge
22
22
Adhesion(s)
22
22
Hypersensitivity/Allergic reaction
21
21
No Patient Involvement
20
20
Fracture, Arm
20
20
Toxicity
18
18
Limb Fracture
18
18
Scar Tissue
18
18
Synovitis
18
18
Non-union Bone Fracture
17
17
Fever
16
16
Pulmonary Embolism
15
15
Impaired Healing
15
15
Wound Dehiscence
14
14
Swelling/ Edema
14
14
Erythema
13
13
Hemorrhage/Bleeding
13
13
Death
12
12
Sepsis
11
11
Subluxation
11
11
Weakness
10
10
Sleep Dysfunction
9
9
Cyst(s)
9
9
Abscess
9
9
Damage to Ligament(s)
8
8
Rupture
8
8
Arthralgia
8
8
Thrombus
7
7
Seroma
7
7
Unspecified Musculoskeletal problem
7
7
Pneumonia
6
6
Blood Loss
6
6
Excessive Tear Production
5
5
Loss of consciousness
5
5
Neurological Deficit/Dysfunction
5
5
Septic Shock
5
5
Calcium Deposits/Calcification
5
5
Fatigue
5
5
Edema
4
4
Atrial Fibrillation
4
4
Memory Loss/Impairment
4
4
Muscle Spasm(s)
4
4
Paralysis
4
4
Tissue Breakdown
4
4
Peripheral Nervous Injury
4
4
Bone Shedding Debris
4
4
Malunion of Bone
3
3
Hypoesthesia
3
3
Perforation
3
3
Thrombosis
3
3
Irritation
3
3
Myocardial Infarction
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Dec-17-2020
2
Biomet, Inc.
II
Apr-03-2020
3
DePuy Orthopaedics, Inc.
II
Mar-01-2018
4
DePuy Orthopaedics, Inc.
II
Feb-27-2018
5
Encore Medical, LP
II
Aug-23-2021
6
Encore Medical, LP
II
Oct-16-2020
7
Encore Medical, Lp
II
Mar-28-2018
8
Exactech, Inc.
II
Nov-17-2020
9
Exactech, Inc.
II
Jan-18-2018
10
Materialise N.V.
II
Aug-26-2020
11
Medacta Usa Inc
II
Jan-03-2020
12
Tornier, Inc
II
Jul-12-2021
13
Zimmer Biomet, Inc.
II
Nov-22-2019
14
Zimmer Biomet, Inc.
II
Mar-01-2019
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