MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-08-26 for UNKNOWN ZIMMER B/F HUMERAL STEM manufactured by .
[24162700]
(b)(4). Other devices used: unknown zimmer b/f glenoid,. Unknown zimmer b/f humeral head. This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[24162701]
It is reported the patient had an infection reported in the operative shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2015-01597 |
| MDR Report Key | 5033034 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-08-26 |
| Date of Report | 2015-07-29 |
| Date Mfgr Received | 2015-07-29 |
| Date Added to Maude | 2015-08-26 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ZIMMER B/F HUMERAL STEM |
| Generic Name | SHOULDER PROSTHESIS |
| Product Code | KWR |
| Date Received | 2015-08-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-26 |