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Device
prosthesis, shoulder, non-constrained, metal/polymer cemented
Regulation Description
Shoulder joint metal/polymer non-constrained cemented prosthesis.
Product Code
KWT
Regulation Number
888.3650
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOMET ORTHOPEDICS
SUBSTANTIALLY EQUIVALENT
1
FX SHOULDER USA, INC.
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST, GMBH
SUBSTANTIALLY EQUIVALENT
2
WALDEMAR LINK GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
1. K210899
LINK Embrace Shoulder System- Anatomical Configura
...
MDR Year
MDR Reports
MDR Events
2020
216
216
2021
228
228
2022
274
274
2023
379
379
2024
618
618
2025
59
59
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
642
642
Device Dislodged or Dislocated
305
305
Loosening of Implant Not Related to Bone-Ingrowth
196
196
Detachment of Device or Device Component
161
161
Fracture
157
157
Naturally Worn
99
99
Break
71
71
Insufficient Information
63
63
Unstable
52
52
Appropriate Term/Code Not Available
27
27
Patient Device Interaction Problem
19
19
Migration
19
19
Loss of or Failure to Bond
10
10
Inadequacy of Device Shape and/or Size
9
9
Material Erosion
8
8
Unintended Movement
6
6
Mechanical Problem
6
6
Patient-Device Incompatibility
4
4
Difficult to Insert
4
4
Loss of Osseointegration
4
4
Defective Device
3
3
Misassembly by Users
3
3
Contamination /Decontamination Problem
3
3
Activation, Positioning or Separation Problem
3
3
Malposition of Device
3
3
Noise, Audible
3
3
Loose or Intermittent Connection
3
3
Material Integrity Problem
2
2
Separation Problem
2
2
Inaccurate Information
2
2
Lack of Effect
2
2
Unintended Collision
2
2
Positioning Problem
2
2
Migration or Expulsion of Device
2
2
Biocompatibility
2
2
Fitting Problem
2
2
Off-Label Use
2
2
Improper or Incorrect Procedure or Method
2
2
Separation Failure
2
2
Material Puncture/Hole
1
1
Device-Device Incompatibility
1
1
Disconnection
1
1
Difficult to Remove
1
1
Use of Device Problem
1
1
Material Deformation
1
1
Connection Problem
1
1
Measurement System Incompatibility
1
1
Failure to Align
1
1
Device Fell
1
1
Difficult to Advance
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
544
544
Joint Dislocation
262
262
Pain
224
224
Insufficient Information
181
181
Bacterial Infection
162
162
Bone Fracture(s)
120
120
Unspecified Infection
96
96
No Clinical Signs, Symptoms or Conditions
75
75
Loss of Range of Motion
51
51
Joint Laxity
47
47
Muscle/Tendon Damage
40
40
Osteolysis
26
26
Metal Related Pathology
26
26
Implant Pain
21
21
Subluxation
21
21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
17
17
Inadequate Osseointegration
16
16
No Code Available
14
14
Erosion
14
14
No Information
14
14
No Consequences Or Impact To Patient
13
13
Fall
13
13
Unspecified Tissue Injury
12
12
Device Embedded In Tissue or Plaque
8
8
Swelling/ Edema
7
7
Osteopenia/ Osteoporosis
7
7
Foreign Body In Patient
6
6
Wound Dehiscence
5
5
Inflammation
5
5
Necrosis
5
5
Nerve Damage
4
4
Hematoma
4
4
Erythema
4
4
Limb Fracture
4
4
Numbness
4
4
No Known Impact Or Consequence To Patient
4
4
Injury
3
3
Unspecified Musculoskeletal problem
3
3
Discomfort
3
3
Ossification
3
3
Non-union Bone Fracture
2
2
Cognitive Changes
2
2
Arthritis
2
2
Post Traumatic Wound Infection
2
2
Arthralgia
2
2
Muscle Weakness
2
2
Stroke/CVA
2
2
Impaired Healing
2
2
Limited Mobility Of The Implanted Joint
2
2
Purulent Discharge
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Exactech, Inc.
II
Jan-18-2024
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