MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-08-06 for AS INVERSE GLENOID FIXATION 01.04223.200 manufactured by Zimmer Gmbh.
[1112666]
It was reported that these implants were removed due to the glenoid baseplate having separated from the glenoid. The humeral cup and polyethylene cup show significant wear radiographically as well as scapular notching.
Patient Sequence No: 1, Text Type: D, B5
[8280681]
Information was forwarded from the owner establishment - zimmer inc. (establishment). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2009-00360 |
| MDR Report Key | 1435629 |
| Report Source | 05,08 |
| Date Received | 2009-08-06 |
| Date of Report | 2009-07-09 |
| Date of Event | 2009-05-20 |
| Date Facility Aware | 2009-07-09 |
| Report Date | 2009-07-09 |
| Date Mfgr Received | 2009-07-09 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2009-08-13 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DALE MILLER |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5742676131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AS INVERSE GLENOID FIXATION |
| Generic Name | ANATOMICAL SHOULDER INVERSE/REVERSE |
| Product Code | KYM |
| Date Received | 2009-08-06 |
| Returned To Mfg | 2009-07-20 |
| Catalog Number | 01.04223.200 |
| Lot Number | 2429311 |
| Device Expiration Date | 2013-01-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 9 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 | 2009-08-06 |