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 2016-04-07 for UNKNOWN ZIMMER BIGLIANA/FLATOW SHOULDER manufactured by Zimmer Inc.
[42075684]
(b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[42075725]
It is reported that the patient was revised due to infection.
Patient Sequence No: 1, Text Type: D, B5
[50200255]
No device or photos were received; therefore the condition of the component is unknown. Device history records cannot be reviewed since the part and lot number is unknown. This device is used for treatment. Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Product history search cannot be completed since the part and lot number is unknown. Patient? S activity level and adherence to rehabilitation protocol is unknown. 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 or contributed to any patient infection. A definite root cause cannot be determined with the information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2016-00956 |
| MDR Report Key | 5554803 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-04-07 |
| Date of Report | 2016-03-15 |
| Date Mfgr Received | 2016-07-11 |
| Date Added to Maude | 2016-04-07 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ZIMMER BIGLIANA/FLATOW SHOULDER |
| Generic Name | SHOULDER PROSTHESIS |
| Product Code | KWR |
| Date Received | 2016-04-07 |
| 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 | 2016-04-07 |