MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-07-25 for VANGUARD PFR FEMORAL RIGHT SM 11-150906 manufactured by Biomet Spain, S.l..
[80893796]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation due to location of device is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[80893797]
It was reported that a patient underwent an initial knee arthroplasty procedure. Subsequently they underwent a revision procedure due to progression of disease. The patient was converted to a total knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009610576-2017-00030 |
| MDR Report Key | 6739786 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-07-25 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2017-09-20 |
| Date Added to Maude | 2017-07-25 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANGUARD PFR FEMORAL RIGHT SM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | KRR |
| Date Received | 2017-07-25 |
| Catalog Number | 11-150906 |
| Lot Number | 2014041302 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-07-25 |