Device Type ID | 4579 |
Device Name | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
Regulation Description | Hip Joint Femoral (hemi-hip) Metal/polymer Cemented Or Uncemented 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 | 510(k) |
CFR Regulation Number | 888.3390 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KWY |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4579 |
Device | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
Product Code | KWY |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Hip Joint Femoral (hemi-hip) Metal/polymer Cemented Or Uncemented Prosthesis. |
CFR Regulation Number | 888.3390 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
IMPLANTS INTERNATIONAL, LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ONKOS SURGICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOTAL JOINT ORTHOPEDICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UNITED ORTHOPEDIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |
Device Problems | |
---|---|
Insufficient Information | 2027 |
Appropriate Term/Code Not Available | 1001 |
Device Dislodged Or Dislocated | 644 |
Adverse Event Without Identified Device Or Use Problem | 377 |
Naturally Worn | 222 |
Metal Shedding Debris | 196 |
Corroded | 177 |
Material Disintegration | 131 |
Loss Of Osseointegration | 118 |
Noise, Audible | 98 |
Fracture | 95 |
Material Erosion | 69 |
Migration Or Expulsion Of Device | 60 |
Loose Or Intermittent Connection | 53 |
Break | 49 |
Difficult To Insert | 42 |
Disassembly | 42 |
Malposition Of Device | 37 |
Fitting Problem | 30 |
Biocompatibility | 20 |
Unstable | 20 |
Loss Of Or Failure To Bond | 17 |
Migration | 14 |
Device Contamination With Chemical Or Other Material | 13 |
Device Slipped | 12 |
Detachment Of Device Or Device Component | 12 |
Detachment Of Device Component | 11 |
Device Operates Differently Than Expected | 9 |
Difficult To Remove | 8 |
Compatibility Problem | 8 |
Material Integrity Problem | 8 |
Osseointegration Problem | 8 |
Difficult To Position | 8 |
Mechanical Problem | 8 |
Packaging Problem | 7 |
Positioning Problem | 7 |
Inadequacy Of Device Shape And/or Size | 7 |
Material Deformation | 6 |
Material Discolored | 6 |
Failure To Osseointegrate | 6 |
Material Separation | 5 |
Device Damaged Prior To Use | 5 |
Device Markings / Labelling Problem | 4 |
Separation Failure | 4 |
Unintended Movement | 4 |
Bent | 4 |
Degraded | 4 |
Device Difficult To Setup Or Prepare | 4 |
Use Of Device Problem | 4 |
Connection Problem | 4 |
Component Missing | 3 |
No Apparent Adverse Event | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Device-Device Incompatibility | 3 |
Scratched Material | 3 |
Disconnection | 3 |
Device Expiration Issue | 3 |
Crack | 2 |
Defective Device | 2 |
Separation Problem | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Device Damaged By Another Device | 2 |
Device Packaging Compromised | 2 |
Misconnection | 2 |
Failure To Adhere Or Bond | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Delivered As Unsterile Product | 2 |
Contamination / Decontamination Problem | 1 |
Difficult Or Delayed Positioning | 1 |
Misassembled | 1 |
Material Split, Cut Or Torn | 1 |
Heads | 1 |
Material Puncture / Hole | 1 |
Gradient Increase | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
Particulates | 1 |
Suction Failure | 1 |
Defective Component | 1 |
Handpiece | 1 |
Cups | 1 |
Patient-Device Incompatibility | 1 |
Device Operational Issue | 1 |
Human-Device Interface Problem | 1 |
Material Twisted / Bent | 1 |
Mechanical Jam | 1 |
Loosening Of Implant Not Related To Bone-Ingrowth | 1 |
Positioning Failure | 1 |
Excess Flow Or Over-Infusion | 1 |
Material Too Rigid Or Stiff | 1 |
Device Subassembly | 1 |
Partial Blockage | 1 |
Sticking | 1 |
Loose | 1 |
Peeled / Delaminated | 1 |
Nonstandard Device | 1 |
Failure To Align | 1 |
Entrapment Of Device | 1 |
Dull, Blunt | 1 |
Failure To Disconnect | 1 |
Total Device Problems | 5798 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Ortho Development Corporation | II | Aug-17-2014 |
2 | Smith & Nephew, Inc. | II | Nov-03-2016 |
3 | Zimmer Biomet, Inc. | II | Nov-07-2018 |
4 | Zimmer Biomet, Inc. | II | Mar-14-2018 |
5 | Zimmer Biomet, Inc. | II | Feb-15-2018 |
6 | Zimmer Biomet, Inc. | II | Feb-22-2016 |
7 | Zimmer Manufacturing B.V. | II | Mar-12-2016 |
8 | Zimmer, Inc. | II | Feb-20-2014 |