MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-13 for SMR HUMERAL HEAD ?50 MM 1322.09.500 manufactured by Limacorporate Spa.
[183374175]
By checking the dhr of the lot #1314571, no pre-existing anomaly was detected. This is the first and only complaint received on this lot #. We will submit a final incident report once the investigation will be concluded.
Patient Sequence No: 1, Text Type: N, H10
[183374176]
Revision surgery due to dislocation occurred on (b)(6) 2014. At patient's 3 week follow up appointment (primary surgery was performed on (b)(6) 2014), the patient was found to have a posterior dislocation of the right shoulder. According to the information reported, the patient did not have any fall or injury that contributed to dislocation. Event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008021110-2020-00015 |
| MDR Report Key | 9829920 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2014-03-26 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS FEDERICA MALVASO |
| Manufacturer Street | VIA NAZIONALE 52 |
| Manufacturer City | VILLANOVA DI SAN DANIELE, UDINE 33038 |
| Manufacturer Country | IT |
| Manufacturer Postal | 33038 |
| Manufacturer G1 | LIMACORPORATE SPA |
| Manufacturer Street | VIA NAZIONALE 52 |
| Manufacturer City | VILLANOVA DI SAN DANIELE, UDINE 33038 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 33038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMR HUMERAL HEAD ?50 MM |
| Generic Name | SMR HUMERAL HEAD ?50 MM |
| Product Code | KWT |
| Date Received | 2020-03-13 |
| Model Number | 1322.09.500 |
| Lot Number | 1314571 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIMACORPORATE SPA |
| Manufacturer Address | VIA NAZIONALE 52 VILLANOVA DI SAN DANIELE, UDINE 33038 IT 33038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |