| Device Type ID | 4621 |
| Device Name | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Regulation Description | Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous 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 | 888.3353 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MEH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4621 |
| Device | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Product Code | MEH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis. |
| CFR Regulation Number | 888.3353 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CORIN USA LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DEPUY INTL., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEPUY ORTHOPAEDICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEPUY SYNTHES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMPLANTCAST | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIMACORPORATE S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHO DEVELOPMENT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO DEVELOPMENT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITH & NEPHEW INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITH & NEPHEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WALDEMAR LINK GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 525 |
Device Dislodged Or Dislocated | 131 |
Adverse Event Without Identified Device Or Use Problem | 75 |
Fracture | 68 |
Break | 46 |
Material Integrity Problem | 43 |
Corroded | 41 |
Loss Of Osseointegration | 40 |
Mechanical Problem | 38 |
Degraded | 34 |
Naturally Worn | 29 |
Malposition Of Device | 28 |
Material Deformation | 28 |
Migration Or Expulsion Of Device | 26 |
Appropriate Term/Code Not Available | 25 |
Loose Or Intermittent Connection | 23 |
Positioning Problem | 18 |
Metal Shedding Debris | 16 |
Osseointegration Problem | 13 |
Noise, Audible | 11 |
Device Slipped | 10 |
Material Erosion | 9 |
Device-Device Incompatibility | 9 |
Unstable | 9 |
Detachment Of Device Component | 8 |
Inadequacy Of Device Shape And/or Size | 8 |
Unintended Movement | 8 |
Packaging Problem | 6 |
No Apparent Adverse Event | 6 |
Difficult To Remove | 5 |
Device Operates Differently Than Expected | 5 |
Manufacturing, Packaging Or Shipping Problem | 5 |
Scratched Material | 4 |
Migration | 4 |
Material Discolored | 3 |
Use Of Device Problem | 3 |
Tip | 3 |
Disassembly | 3 |
Detachment Of Device Or Device Component | 3 |
Sticking | 3 |
Fitting Problem | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Device Packaging Compromised | 3 |
Loosening Of Implant Not Related To Bone-Ingrowth | 3 |
Material Protrusion / Extrusion | 2 |
Material Fragmentation | 2 |
Loss Of Power | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Adapter (Adaptor) | 2 |
Defective Device | 2 |
Component Falling | 2 |
Device Markings / Labelling Problem | 2 |
Screw | 2 |
Compatibility Problem | 2 |
Handpiece | 1 |
Unexpected Therapeutic Results | 1 |
Device Inoperable | 1 |
Defective Component | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Failure To Adhere Or Bond | 1 |
Contamination During Use | 1 |
Cable | 1 |
Cups | 1 |
Patient-Device Incompatibility | 1 |
Heads | 1 |
Incorrect Measurement | 1 |
Delamination | 1 |
Delivered As Unsterile Product | 1 |
Device Displays Incorrect Message | 1 |
Contamination / Decontamination Problem | 1 |
Connection Problem | 1 |
Difficult To Insert | 1 |
Device Damaged Prior To Use | 1 |
Failure To Disconnect | 1 |
Implant, Removal Of | 1 |
Nonstandard Device | 1 |
Difficult To Position | 1 |
Biological Environmental Factor | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Trocar | 1 |
Accessory Incompatible | 1 |
Off-Label Use | 1 |
Device Issue | 1 |
Separation Failure | 1 |
Device Damaged By Another Device | 1 |
Unsealed Device Packaging | 1 |
Extractor | 1 |
Plate | 1 |
Ring | 1 |
Mechanical Jam | 1 |
Patient Device Interaction Problem | 1 |
Inaccurate Information | 1 |
| Total Device Problems | 1442 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Depuy Orthopaedics Inc. | II | Nov-21-2016 |
| 2 | Exactech, Inc. | II | Jan-18-2018 |
| 3 | Exactech, Inc. | II | Nov-02-2015 |
| 4 | Signature Orthopedics Pty Limited | II | Mar-06-2018 |
| 5 | Smith & Nephew, Inc. | II | Jan-04-2017 |
| 6 | Smith & Nephew, Inc. | II | Jul-28-2016 |
| 7 | Stryker Howmedica Osteonics Corp. | II | Feb-03-2015 |
| 8 | Stryker Howmedica Osteonics Corp. | II | Apr-02-2014 |
| 9 | Waldemar Link GmbH & Co. KG (Mfg Site) | II | Jan-11-2019 |
| 10 | Zimmer Gmbh | II | Feb-20-2015 |