MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2015-12-02 for UNKNOWN ZIMMER SHOULDER manufactured by Zimmer Inc.
[32516193]
Information was received from a consumer who is not required to complete form 3500a. (b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[32516194]
It is reported that the patient is experiencing a rash around the incision and breaking out.
Patient Sequence No: 1, Text Type: D, B5
[39216396]
Operative notes and x-rays were requested however none provided. The devices remain implanted therefore no devices or photos were returned. The devices part numbers and lot numbers were not provided therefore their device history records could not be reviewed. The devices were used for treatment. Due to the lack of part numbers and lot numbers a complaint search could not be performed. Device compatibility could not be confirmed due to the lack of part numbers. With the provided information an exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2015-02494 |
| MDR Report Key | 5261086 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2015-12-02 |
| Date of Report | 2015-11-04 |
| Date Mfgr Received | 2016-02-05 |
| Date Added to Maude | 2015-12-02 |
| 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 | 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 SHOULDER |
| Generic Name | SHOULDER PROSTHESIS |
| Product Code | KWR |
| Date Received | 2015-12-02 |
| 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 | 2015-12-02 |