MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-10 for VG 360 UNIV PST FM AUG 75X10 N/A 185428 manufactured by Zimmer Biomet, Inc..
[170206800]
(b)(4). Concomitant medical products: biomet splined knee stem catalog 141658 lot 039130, unknown femoral component lot 3422678, vanguard 360 femoral augment catalog 185428 lot 723710, tibial bearing lot 985950, biomet tibial locking bar catalog 141205 lot 884680, biomet 360 tibial tray catalog 185206 lot 184200, biomet splined knee stem catalog 148306 lot 277800, biomet 360 offset adapter catalog 185211 lot 497570, unknown cobalt bone cement. The product has not been returned to zimmer biomet for investigation as it still remains implanted. 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
[170206801]
It was reported the patient has been indicated for a left knee revision arthroplasty approximately 18 months post implantation due to ongoing femoral aseptic femoral loosening with severe bone loss. No revision has been reported to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-05519 |
| MDR Report Key | 9446747 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-10 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-09-19 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2017-10-06 |
| Date Added to Maude | 2019-12-10 |
| 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 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VG 360 UNIV PST FM AUG 75X10 |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2019-12-10 |
| Model Number | N/A |
| Catalog Number | 185428 |
| Lot Number | 408680 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-12-10 |