| Device Type ID | 4560 |
| Device Name | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Regulation Description | Hip Joint Metal/metal Semi-constrained, With An Uncemented Acetabular Component, Prosthesis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | PMA |
| CFR Regulation Number | 888.3330 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KWA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4560 |
| Device | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Product Code | KWA |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Hip Joint Metal/metal Semi-constrained, With An Uncemented Acetabular Component, Prosthesis. |
| CFR Regulation Number | 888.3330 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 13032 |
Appropriate Term/Code Not Available | 6270 |
Metal Shedding Debris | 2085 |
Adverse Event Without Identified Device Or Use Problem | 1707 |
Device Dislodged Or Dislocated | 1705 |
Loss Of Osseointegration | 1430 |
Corroded | 1102 |
Naturally Worn | 1076 |
Material Erosion | 955 |
Noise, Audible | 920 |
Migration Or Expulsion Of Device | 899 |
Material Disintegration | 792 |
Malposition Of Device | 491 |
Fracture | 481 |
Loose Or Intermittent Connection | 412 |
Break | 263 |
Disassembly | 227 |
Unstable | 196 |
Nonstandard Device | 134 |
Biocompatibility | 117 |
Difficult To Remove | 102 |
Loss Of Or Failure To Bond | 92 |
Separation Failure | 86 |
Compatibility Problem | 81 |
Device Operates Differently Than Expected | 76 |
Mechanical Problem | 76 |
Device Packaging Compromised | 75 |
Migration | 72 |
Device Slipped | 56 |
Osseointegration Problem | 53 |
Inadequacy Of Device Shape And/or Size | 50 |
Positioning Problem | 48 |
Device Contaminated During Manufacture Or Shipping | 47 |
Tear, Rip Or Hole In Device Packaging | 46 |
Failure To Adhere Or Bond | 46 |
Patient-Device Incompatibility | 43 |
Device Contamination With Chemical Or Other Material | 41 |
Failure To Osseointegrate | 40 |
Fitting Problem | 39 |
Packaging Problem | 39 |
Separation Problem | 34 |
Material Separation | 33 |
Material Deformation | 29 |
Material Integrity Problem | 29 |
Loosening Of Implant Not Related To Bone-Ingrowth | 28 |
Detachment Of Device Or Device Component | 27 |
Degraded | 27 |
Device-Device Incompatibility | 24 |
Detachment Of Device Component | 23 |
Difficult To Position | 16 |
Disconnection | 16 |
Difficult To Insert | 15 |
No Apparent Adverse Event | 15 |
Component Missing | 15 |
Material Discolored | 15 |
Device Markings / Labelling Problem | 11 |
Defective Device | 11 |
Device Issue | 11 |
Component Or Accessory Incompatibility | 10 |
Screw | 10 |
Mechanical Jam | 9 |
Crack | 8 |
Delivered As Unsterile Product | 8 |
Implant, Removal Of | 7 |
Failure To Disconnect | 7 |
Scratched Material | 7 |
Unsealed Device Packaging | 6 |
Use Of Device Problem | 6 |
Cups | 6 |
Bent | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Material Protrusion / Extrusion | 4 |
Peeled / Delaminated | 4 |
Unintended Movement | 4 |
Entrapment Of Device | 4 |
Failure To Align | 4 |
Fluid Leak | 3 |
Collapse | 3 |
Flaked | 3 |
Off-Label Use | 3 |
Device Damaged By Another Device | 3 |
Defective Component | 3 |
Product Quality Problem | 3 |
Material Twisted / Bent | 3 |
Shipping Damage Or Problem | 3 |
Particulates | 2 |
Material Puncture / Hole | 2 |
Delamination | 2 |
Connection Problem | 2 |
Misassembled | 2 |
Component Incompatible | 2 |
Computer Operating System Problem | 2 |
Material Rupture | 2 |
Dull, Blunt | 2 |
Ambient Noise Problem | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Device Or Device Fragments Location Unknown | 2 |
Torn Material | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Adapter (Adaptor) | 1 |
| Total Device Problems | 36047 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet, Inc. | II | Feb-17-2015 |
| 2 | DePuy Orthopaedics, Inc. | II | Jul-21-2014 |
| 3 | Encore Medical, Lp | II | Feb-11-2017 |
| 4 | Zimmer Biomet, Inc. | II | Dec-19-2018 |
| 5 | Zimmer Biomet, Inc. | II | Aug-14-2018 |
| 6 | Zimmer Biomet, Inc. | II | Dec-29-2017 |
| 7 | Zimmer Biomet, Inc. | II | Feb-22-2016 |
| 8 | Zimmer Gmbh | II | Feb-20-2015 |
| 9 | Zimmer, Inc. | I | Jun-08-2015 |