MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-01-14 for UNKNOWN ZIMMER TM REVERSE SHOULDER GLENOID manufactured by Zimmer Inc.
[36010296]
(b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[36010297]
It is reported the glenoid appears to have separated from the metal and the polyethylene.
Patient Sequence No: 1, Text Type: D, B5
[38322420]
Information has been received and the device that has contributed to the reported event is manufactured by zimmer (b)(4). Please reference 1822565-2016-00084.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2016-00084 |
| MDR Report Key | 5368235 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-01-14 |
| Date of Report | 2015-12-21 |
| Date Mfgr Received | 2016-02-02 |
| Date Added to Maude | 2016-01-14 |
| 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 TM REVERSE SHOULDER GLENOID |
| Generic Name | SHOULDER PROSTHESIS |
| Product Code | KWR |
| Date Received | 2016-01-14 |
| 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 | 2016-01-14 |