MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-12-09 for UNKNOWN ZIMMER COONRAD MORREY ELBOW manufactured by Zimmer Inc.
[33043220]
(b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[33043221]
It is reported that the patient is scheduled for revision surgery for an unknown reason. The patient is being revised to a custom distal humerus component.
Patient Sequence No: 1, Text Type: D, B5
[39227542]
No devices or photos were returned therefore a determination on the condition of the devices could not be made. The devices part numbers and lot number were not provided therefore their device history records could not be reviewed and a complaint search could not be performed. The devices were used for treatment. With the provided information an exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2015-02623 |
| MDR Report Key | 5278189 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-12-09 |
| Date of Report | 2015-11-20 |
| Date Mfgr Received | 2016-02-23 |
| Date Added to Maude | 2015-12-09 |
| 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 COONRAD MORREY ELBOW |
| Generic Name | ELBOW PROSTHESIS |
| Product Code | KWR |
| Date Received | 2015-12-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER INC |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-09 |