MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-12 for HUMERIS 105-3613 manufactured by Fx Solutions.
[188257966]
Surgery was delayed for an additional four hours. Surgeon decision to switch from anatomic to reverse after bending peripheral pegs on glenoid. Difficulty engaging baseplate with 36 eccentric glenosphere with screw. Difficulty with 36 centered glenosphere with screw and size 12 stem and 36/+3 humeral cup, due to stem spinning out when reduced. Tried size 16 stem and 36/+6 humeral cup, but continued to dislocate after reduction. Size 18 stem, reversed adapter for +9mm, 40/+3 humeral cup, and 40 eccentric glenosphere with screw implanted successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009532798-2020-00010 |
| MDR Report Key | 9824300 |
| Report Source | OTHER |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2018-04-04 |
| Date Added to Maude | 2020-03-12 |
| 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 | SHOUDLER PROTHESIS |
| Product Code | HSD |
| Date Received | 2020-03-12 |
| Catalog Number | 105-3613 |
| Lot Number | L2569 |
| 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 | 2020-03-12 |