MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-04-13 for AS INVERSE GLENOID FIXATION 0104223200 manufactured by Zimmer Gmbh.
[22096412]
It is reported that patient underwent revision due to pain and implant loosening (glenoid component). Initial surgery was on (b)(6) 2006. This complaint is related to the anatomical shoulder inverse/reverse clinical study. No retrievals are available for investigation.
Patient Sequence No: 1, Text Type: D, B5
[22256413]
Information was forwarded from the owner establishment, zimmer (b)(4), clinicals department, which markets the devices and leads the above mentioned clinical study in (b)(4). The manufacturer did not receive explanted 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. It is not suspected that product failure lead to the alleged event. Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be filed. The need for further corrective measures is not indicated at this time and zimmer (b)(4) considers this case closed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2011-00228 |
| MDR Report Key | 2071763 |
| Report Source | 05,08 |
| Date Received | 2011-04-13 |
| Date of Report | 2011-03-22 |
| Date of Event | 2007-01-17 |
| Date Mfgr Received | 2011-03-22 |
| Date Added to Maude | 2011-05-02 |
| 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 | 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 | 2011-04-13 |
| Catalog Number | 0104223200 |
| Lot Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| 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 | 2011-04-13 |