MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-27 for TNBN POL COCR I-BEAM TRAY 67 N/A 141242TNBN manufactured by Biomet Spain, S.l..
[128386232]
(b)(4). Report source, foreign - event occurred in (b)(6). This device is not manufactured by zimmer biomet in the united states; however, we are filing this report as zimmer biomet manufactures a similar device in the united states under 510k number k945028.
Patient Sequence No: 1, Text Type: N, H10
[128386233]
Patient is suspected allergic reaction to the material in the implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009610576-2018-00039 |
| MDR Report Key | 8105305 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-27 |
| Date Mfgr Received | 2018-10-30 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2018-11-27 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | BIOMET SPAIN, S.L. |
| Manufacturer Street | CALLE ISLAS BALEARES, #50 P.O. BOX 96 |
| Manufacturer City | FUENTE DEL JARRO, VALENCIA 46988 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 46988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TNBN POL COCR I-BEAM TRAY 67 |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | KRR |
| Date Received | 2018-11-27 |
| Model Number | N/A |
| Catalog Number | 141242TNBN |
| Lot Number | 2017110881 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPAIN, S.L. |
| Manufacturer Address | CALLE ISLAS BALEARES, #50 P.O. BOX 96 FUENTE DEL JARRO, VALENCIA 46988 SP 46988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-11-27 |