MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-08-14 for POLISHED FINNED TIB TRAY 71MM N/A 141253 manufactured by Biomet Spain, S.l..
[116995634]
(b)(4). Combination of reference and lot provided has not been manufactured by (b)(4)according to our erp. 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. Concomitant medical product: associate product (b)(4). Manufactured date unknown due to combination of reference and lot provided is incorrect. Product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[116995635]
A surgery occurred for infection. The prosthesis was implanted on (b)(6) 2006 for knee arthrosis. Three components have been explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009610576-2018-00029 |
| MDR Report Key | 7780182 |
| Report Source | FOREIGN |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-09 |
| Date of Event | 2013-07-09 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2018-08-14 |
| 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 71MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | KRR |
| Date Received | 2018-08-14 |
| Model Number | N/A |
| Catalog Number | 141253 |
| Lot Number | 2011110282 |
| 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; 2. Required No Informationntervention | 2018-08-14 |