MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02 report with the FDA on 2013-01-22 for AS INVERSE GLENOID FIXATION 0104223200 manufactured by Zimmer Gmbh.
[15802307]
The mfr did not receive devices, x-rays, or other source documents for review. Where lot numbers were received for the explanted devices, the device history records were reviewed and found to be conforming. The cause for this specific clinical event cannot be ascertained from the info provided. However, there is no indication for a product failure. Should add'l info become available and/or the devices be returned for eval and an investigation result be available, that changes this assessment, an amended medical device report will be filed. The need for corrective measures is not indicated at this time and zimmer (b)(4) considers this case as closed. Zimmer's reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[15860638]
It was reported that the pt received an inverse glenoid fixation on (b)(6) 2008 and underwent a revision surgery on (b)(6) 2009 due to loosening of the glenoid base plate. The complication was reported by the study site as not being related to the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613350-2013-01278 |
| MDR Report Key | 2930362 |
| Report Source | 02 |
| Date Received | 2013-01-22 |
| Date of Report | 2013-01-10 |
| Date of Event | 2009-10-06 |
| Date Mfgr Received | 2013-01-10 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2013-01-29 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | PO BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5742676 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AS INVERSE GLENOID FIXATION |
| Generic Name | AS INVERSE GLENOID FIXATION |
| Product Code | KYM |
| Date Received | 2013-01-22 |
| Catalog Number | 0104223200 |
| Lot Number | 2450051 |
| Device Expiration Date | 2013-05-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-01-22 |