MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-02 for HUMERIS 400-1102 manufactured by Fx Solutions.
[188257885]
The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.
Patient Sequence No: 1, Text Type: N, H10
[188257886]
Revision surgery occurred (b)(6) 2020 for an unknown reason. All product fx solutions were removed : humeral steam size 12, double taper, centered head, 3-4 pegs glenoid. Primary surgery occurred in 2019. As far as we know, it has been highlighted during the revision surgery that the glenoid was unsealed (unknown reason). All the component part of the prothesis were removed, the replacement products are not fx products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009532798-2020-00096 |
| MDR Report Key | 9774076 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2018-07-23 |
| Date Added to Maude | 2020-03-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CEDRIC JOLY |
| Manufacturer Street | 1663 RUE DE MAJORNAS |
| Manufacturer City | VIRIAT, 01440 |
| Manufacturer Country | FR |
| Manufacturer Postal | 01440 |
| Manufacturer G1 | FX SOLUTIONS |
| Manufacturer Street | 1663 RUE DE MAJORNAS |
| Manufacturer City | VIRIAT, 01440 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 01440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMERIS |
| Generic Name | SHOULDER PROTHESIS |
| Product Code | HSD |
| Date Received | 2020-03-02 |
| Catalog Number | 400-1102 |
| Lot Number | M0945 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FX SOLUTIONS |
| Manufacturer Address | 1663 RUE DE MAJORNAS VIRIAT, 01440 FR 01440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-02 |