MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-07-22 for AS INVERSE GLENOID FIXATION 01.04223.200 manufactured by Zimmer Gmbh.
[1093769]
It was reported that pt will be revised due to no bony ingrowth on the implant backside of the glenoid.
Patient Sequence No: 1, Text Type: D, B5
[8349840]
This report will be amended when our investigation is complete. Associated components: product name: a. S. Humeral stem 10. 5 uncemented, ref number: 01. 04201. 102, lot number: 2331017. Inverse/reverse screw system, 4. 5-18, 01. 04223. 018, unk. Inverse/reverse screw system, 4. 5-36, 01. 04223. 036, unk. As inverse humeral cup, off center, 01. 04223. 106, 2339898. As inverse glenoid head 36, 01. 04223. 236, unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2009-00337 |
| MDR Report Key | 1424135 |
| Report Source | 05,08 |
| Date Received | 2009-07-22 |
| Date of Report | 2009-04-24 |
| Date of Event | 2009-04-24 |
| Date Facility Aware | 2009-04-24 |
| Report Date | 2009-04-24 |
| Date Mfgr Received | 2009-04-24 |
| Date Added to Maude | 2009-08-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTOF MUELLER |
| Manufacturer Street | SULZER ALLEE 8 |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8404 |
| Manufacturer Phone | 522627210 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AS INVERSE GLENOID FIXATION |
| Generic Name | ANATOMICA GLENOID COMPONENT |
| Product Code | KYM |
| Date Received | 2009-07-22 |
| Catalog Number | 01.04223.200 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 22 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-07-22 |