MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-17 for VANGUARD PFR FEMORAL LT SM N/A 11-150908 manufactured by Biomet Spain, S.l..
[108484292]
(b)(4). Event date unknown. Implant surgery was (b)(6) 2015. Concomitant medical products: p/n 184784, lot 608490. P/n 00-1112-140-01, lot 80424395. Patient reports allergy (but not confirmed). Ref. (b)(4). Vanguard pfr femoral lt sm was cleared in the u. S. Under 510(k) k000827, fda product code krr. This event was previously reported by the patient under mw5076326. Product remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[108484293]
It was reported that a patient underwent an initial knee procedure on (b)(6) 2015. It was reported that the patient experienced continuously with pain, swelling and stiffness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009610576-2018-00017 |
| MDR Report Key | 7521358 |
| Report Source | CONSUMER |
| Date Received | 2018-05-17 |
| Date of Report | 2018-05-15 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2014-05-13 |
| Date Added to Maude | 2018-05-17 |
| 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 | VANGUARD PFR FEMORAL LT SM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | KRR |
| Date Received | 2018-05-17 |
| Model Number | N/A |
| Catalog Number | 11-150908 |
| Lot Number | 2014040696 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Deathisabilit | 2018-05-17 |