MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for HUMELOCK REVERSED 105-0024 manufactured by Fx Solutions.
[184272271]
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
[184272272]
Revision surgery due to a dismantling occurred (b)(6) 2019. All the component parts of the prothesis were removed (? 36/12 humeral stem,? 36 glenosphere,? 36+6 humeral cup, glenoid baseplate and associated screws), no information available about the replacement products. Patient underwent two previous revision surgeries for the same problem ((b)(6) 2019 and (b)(6) 2019). During the second revision surgery the surgeon removed a bony margin near the glenoid baseplate but did not changed it. Primary surgery occurred (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009532798-2020-19499 |
| MDR Report Key | 9859832 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-10-04 |
| Device Manufacturer Date | 2018-10-04 |
| Date Added to Maude | 2020-03-20 |
| 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 | HUMELOCK REVERSED |
| Generic Name | REVERSED SHOULDER PROTHESIS |
| Product Code | PHX |
| Date Received | 2020-03-20 |
| Catalog Number | 105-0024 |
| Lot Number | M2317 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-20 |