MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-04 for HUMERIS 109-4520 manufactured by Fx Solutions.
[182021875]
Patient's second revision surgery, due to breakage of two standard screws on glenoid side. Surgeon explanted all glenoid components and replaced with those from a different manufacturer. Additionally, surgeon upsized the humeral cup. Patient's primary surgery was (b)(6) 2018. Patient's first revision converted anatomic shoulder to a reverse due to failing rotator cuff approximately 8 months later, and was not previously reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009532798-2020-00003 |
| MDR Report Key | 9785327 |
| Report Source | OTHER |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-27 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2018-10-31 |
| Date Added to Maude | 2020-03-04 |
| 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 | 2020-03-04 |
| Catalog Number | 109-4520 |
| Lot Number | M2995 |
| 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 | 2020-03-04 |