MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-08-31 for A.S. GLENOID S ZEMENTIERT 01.04214.340 manufactured by Zimmer Gmbh.
[710579]
Total shoulder failed, glenoid was loose and removed arthroscopically. Pain, loosening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613350-2007-00047 |
| MDR Report Key | 905768 |
| Report Source | 06 |
| Date Received | 2007-08-31 |
| Date of Report | 2007-07-31 |
| Date of Event | 2007-06-18 |
| Date Facility Aware | 2007-08-23 |
| Report Date | 2007-08-31 |
| Date Added to Maude | 2007-09-06 |
| 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 | CHRISTOF MULLER |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8404 |
| Manufacturer Phone | 22627210 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A.S. GLENOID S ZEMENTIERT |
| Generic Name | INLAY |
| Product Code | KYM |
| Date Received | 2007-08-31 |
| Catalog Number | 01.04214.340 |
| Lot Number | 2219744 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 882174 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | WINTERTHUR SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-08-31 |