MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-06-09 for REVERSE SHOULDER SYSTEM 508-32-104 manufactured by Encore Medical, L.p..
[15500073]
Revision surgery-glenoid baseplate loosened and glenoid head and baseplate were removed and was converted to hemi with original rsp stem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644408-2008-00179 |
| MDR Report Key | 1059602 |
| Report Source | 07 |
| Date Received | 2008-06-09 |
| Date of Report | 2008-05-18 |
| Date of Event | 2008-05-18 |
| Date Mfgr Received | 2008-05-18 |
| Device Manufacturer Date | 2006-12-27 |
| Date Added to Maude | 2009-05-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ALBERT ALONSO |
| Manufacturer Street | 9800 METRIC BLVD. |
| Manufacturer City | AUSTIN TX 78758 |
| Manufacturer Country | US |
| Manufacturer Postal | 78758 |
| Manufacturer Phone | 5128346235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVERSE SHOULDER SYSTEM |
| Generic Name | GLENOID BASEPLATE |
| Product Code | KYM |
| Date Received | 2008-06-09 |
| Returned To Mfg | 2008-05-28 |
| Catalog Number | 508-32-104 |
| Lot Number | 53833259 |
| Device Expiration Date | 2012-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENCORE MEDICAL, L.P. |
| Manufacturer Address | AUSTIN TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 508 | 1. Required No Informationntervention | 2008-06-09 |