MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for HUMELOCK II 106-3900 manufactured by Fx Solutions.
[189032458]
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
[189032459]
Revision surgery due to a dismantling occurred (b)(6) 2019. This was due to a bad impact of the centered head into the humeral stem due to an interposition of soft tissues between the head and the stem. The centered head and the double taper were removed and replaced. Primary surgery occurred (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009532798-2020-19117 |
| MDR Report Key | 9841514 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-17 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-02-26 |
| Device Manufacturer Date | 2018-07-23 |
| Date Added to Maude | 2020-03-17 |
| 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 II |
| Generic Name | SHOULDER PROTHESIS |
| Product Code | HSD |
| Date Received | 2020-03-17 |
| Catalog Number | 106-3900 |
| Lot Number | M1057 |
| 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 | 2020-03-17 |