MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2015-10-01 for UNKNOWN ZIMMER REVERSE SHOULDER manufactured by Zimmer Inc.
[27200673]
Information was received from a distributor 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
[27200674]
It was reported that a patient underwent a two-stage revision for infection with the second stage occurring on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
[29950065]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[32907581]
Operative notes were requested however none provided. No devices or photos were received; therefore the condition of the components is unknown. The part and lot numbers of the product are unknown; therefore the device history records could not be reviewed. These products were used for treatment. The complaint history for these products could not be reviewed due to the lack of lot numbers. It could not be confirmed if the devices are an approved and compatible combination. Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1. 0 x 10-6 or better. Therefore, it is highly unlikely that the specified device caused any patient infection. A definitive root cause cannot be determined with the information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2015-01999 |
| MDR Report Key | 5116216 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2015-10-01 |
| Date of Report | 2015-09-04 |
| Date Mfgr Received | 2015-11-10 |
| Date Added to Maude | 2015-10-01 |
| 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 REVERSE SHOULDER |
| Generic Name | SHOULDER PROSTHESIS |
| Product Code | KWR |
| Date Received | 2015-10-01 |
| 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. Required No Informationntervention | 2015-10-01 |