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Device
prosthesis, hip, semi-constrained, metal/polymer, cemented
Regulation Description
Hip joint metal/polymer semi-constrained cemented prosthesis.
Product Code
JDI
Regulation Number
888.3350
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
2
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
2
MICROPORT ORTHOPEDICS INC.
SUBSTANTIALLY EQUIVALENT
2
ONKOS SURGICAL
SUBSTANTIALLY EQUIVALENT
3
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
UNITED ORTHOPEDIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ZIMMER INC
SUBSTANTIALLY EQUIVALENT
1
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2020
4014
4014
2021
3172
3172
2022
1979
1979
2023
1653
1798
2024
1823
1823
2025
129
129
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4825
4875
Device Dislodged or Dislocated
1872
1872
Naturally Worn
1425
1425
Insufficient Information
997
1077
Fracture
565
585
Break
468
468
Degraded
448
448
Loosening of Implant Not Related to Bone-Ingrowth
391
394
Detachment of Device or Device Component
369
373
Material Erosion
356
356
Corroded
331
331
Appropriate Term/Code Not Available
213
213
Osseointegration Problem
198
198
Unstable
181
181
Migration
179
185
Loss of Osseointegration
150
150
Difficult to Insert
146
146
Noise, Audible
120
120
Loss of or Failure to Bond
98
98
Use of Device Problem
92
92
Material Deformation
90
90
Material Twisted/Bent
89
89
Device Contaminated During Manufacture or Shipping
82
82
Loose or Intermittent Connection
78
78
Packaging Problem
78
78
Patient Device Interaction Problem
70
70
Malposition of Device
69
69
Connection Problem
65
65
Positioning Failure
55
55
Unintended Movement
49
49
Incomplete or Inadequate Connection
42
42
Mechanical Problem
40
42
Tear, Rip or Hole in Device Packaging
34
34
Difficult to Remove
32
32
Off-Label Use
32
32
Mechanical Jam
28
28
Crack
27
27
Material Fragmentation
27
27
Defective Device
27
27
Device Appears to Trigger Rejection
26
26
Physical Resistance/Sticking
26
26
Device-Device Incompatibility
24
24
Biocompatibility
23
23
Inadequacy of Device Shape and/or Size
23
23
Failure to Osseointegrate
22
22
Fitting Problem
22
22
Manufacturing, Packaging or Shipping Problem
21
21
No Apparent Adverse Event
20
20
Migration or Expulsion of Device
17
21
Premature Separation
17
17
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
2818
2818
No Code Available
1743
1743
Joint Dislocation
1720
1720
Insufficient Information
1301
1301
Unspecified Infection
1287
1296
Failure of Implant
1254
1349
No Clinical Signs, Symptoms or Conditions
1208
1208
Foreign Body Reaction
1046
1046
Osteolysis
783
783
Metal Related Pathology
707
707
Ambulation Difficulties
594
594
Joint Laxity
568
568
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
566
566
Bone Fracture(s)
505
519
Injury
450
450
Inflammation
424
424
Inadequate Osseointegration
375
375
Hypersensitivity/Allergic reaction
344
344
No Information
330
330
Test Result
306
306
Swelling/ Edema
282
282
Discomfort
273
273
Fall
270
270
Loss of Range of Motion
217
217
Reaction
211
211
No Known Impact Or Consequence To Patient
180
180
No Consequences Or Impact To Patient
170
170
Unspecified Tissue Injury
169
169
Synovitis
166
166
Adhesion(s)
146
146
Necrosis
144
144
Edema
129
129
No Patient Involvement
122
122
Scar Tissue
121
140
Implant Pain
119
119
Hematoma
109
109
Ossification
104
104
Limited Mobility Of The Implanted Joint
100
100
Physical Asymmetry
94
94
Tissue Damage
94
94
Hemorrhage/Bleeding
78
78
Fatigue
75
75
Distress
73
73
Cyst(s)
71
71
Hip Fracture
70
70
Osteopenia/ Osteoporosis
69
69
Nerve Damage
65
65
Fluid Discharge
64
64
Wound Dehiscence
60
60
Bacterial Infection
60
60
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Jun-25-2024
2
Biomet, Inc.
II
Dec-17-2020
3
Biomet, Inc.
II
Oct-09-2020
4
Biomet, Inc.
II
May-28-2020
5
Corin Ltd
II
Aug-31-2022
6
Corin Ltd
II
Aug-09-2022
7
DePuy Orthopaedics, Inc.
II
Jun-10-2021
8
Exactech, Inc.
II
Sep-09-2022
9
Howmedica Osteonics Corp.
II
Aug-26-2024
10
Howmedica Osteonics Corp.
II
Jan-15-2020
11
MicroPort Orthopedics Inc.
II
Jun-02-2022
12
Zimmer Biomet, Inc.
II
Nov-02-2020
13
Zimmer, Inc.
II
Jul-30-2024
14
Zimmer, Inc.
II
Sep-07-2023
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