MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-05-21 for POLISHED FINNED TIB TRAY 67MM N/A 141252 manufactured by Biomet Spain, S.l..
[108722240]
(b)(4). (b)(6). Concomitant products: vanguard cr tib brg 63/67 x 10mm ref. 183420;lot. 572570; vanguard cr ilok fem-rt 60 ref. 183004;lot. J3943450; series a pat std 31 3 peg ref. 184764;lot. 928210. This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510(k) number k945028. Product remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[108722241]
It was reported that the patient underwent initial right knee arthroplasty on (b)(6) 2017. Subsequently, on (b)(6) 2017, it was reported that the patient underwent knee washout with an evacuation of hematoma of skin of limb plus wound exploration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009610576-2018-00018 |
| MDR Report Key | 7528845 |
| Report Source | FOREIGN |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-18 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2018-04-24 |
| Device Manufacturer Date | 2017-06-15 |
| Date Added to Maude | 2018-05-21 |
| 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 | POLISHED FINNED TIB TRAY 67MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | KRR |
| Date Received | 2018-05-21 |
| Model Number | N/A |
| Catalog Number | 141252 |
| Lot Number | 2017050502 |
| ID Number | N/A |
| 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. Required No Informationntervention | 2018-05-21 |