MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-15 for TURON SHOULDER 521-01-150 manufactured by Encore Medical L.p..
[117255352]
Third revision surgery - due to the patient having pain and a subscapular rupture. The pain plan was to remove the neck, head, and glenoid and revise to a reverse total shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644408-2018-00742 |
| MDR Report Key | 7786631 |
| Date Received | 2018-08-15 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-09-07 |
| Device Manufacturer Date | 2016-08-28 |
| Date Added to Maude | 2018-08-15 |
| 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 | TEFFANY HUTTO |
| Manufacturer Street | 9800 METRIC BLVD |
| Manufacturer City | AUSTIN TX 787585445 |
| Manufacturer Country | US |
| Manufacturer Postal | 787585445 |
| Manufacturer G1 | ENCORE MEDICAL L.P. |
| Manufacturer Street | 9800 METRIC BLVD |
| Manufacturer City | AUSTIN TX 787585445 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 787585445 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TURON SHOULDER |
| Generic Name | TURON KEELED GLENOID, SZ 50MM, EPLUS |
| Product Code | PAO |
| Date Received | 2018-08-15 |
| Model Number | 521-01-150 |
| Catalog Number | 521-01-150 |
| Lot Number | 796N1020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENCORE MEDICAL L.P. |
| Manufacturer Address | 9800 METRIC BLVD AUSTIN TX 787585445 US 787585445 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-15 |