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 2015-09-11 for UNKNOWN COONRAD/MORREY HUMERAL ASSEMBLY manufactured by Zimmer Inc.
[25546782]
Information was received via published literature. (b)(4). Operative notes were requested however none provided. Relevant medical history and adherence to rehabilitation protocol are unknown. 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. The investigation could not verify or identify any evidence of product contribution to the reported problem. Please reference literature at the following location: http://www. Ncbi. Nlm. Nih. Gov/pubmed/25035841.
Patient Sequence No: 1, Text Type: N, H10
[25546783]
It is reported that 2 patients were revised due to infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2015-01789 |
| MDR Report Key | 5070656 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-09-11 |
| Date of Report | 2015-08-20 |
| Date Mfgr Received | 2015-08-20 |
| Date Added to Maude | 2015-09-11 |
| 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 COONRAD/MORREY HUMERAL ASSEMBLY |
| Generic Name | EXTREMITY PROSTHESIS |
| Product Code | KWR |
| Date Received | 2015-09-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-09-11 |