MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-03-27 for VANGUARD 360 KNEE STYSTEM OSSEOTI TIBIAL SLEEVE AUGMENT N/A 185551 manufactured by Zimmer Biomet, Inc..
[140008075]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # 185264 lot # 2924013 vanguard ssk 360 femoral with screw. Item # 185324 lot # 346730 vanguard 360 distal femoral augment 65mm. Item # 185344 lot # 088920 vanguard 360 posterior augment 65mm with bolt. Item # 185384 lot # 002180 vanguard 360 distal femoral augment 10mm x 65mm with bolt. Item # 148307 lot # 877190 splined knee system v2 17mm x 80mm. Item # 185210 lot # 524220 360 offset adaptor 2. 5mm with screws. Item # 185203 lot # 289980 360 tibial tray with ti locking bar and screw 71mm. Item # 148287 lot # 795740 splined knee system v2 12mm x 40mm. Item # 185212 lot # 902910 360 offset adaptor 7. 5mm with screws. Item # 183880 lot # 911630 vanguard dcm tibial bearing 10mm x 71 75 mm. Stryker simplex bone cement. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01403, 0001825034-2019-01404, 0001825034-2019-01405, 0001825034-2019-01406, 0001825034-2019-01407, 0001825034-2019-01408, 0001825034-2019-01412, 0001825034-2019-01413, 0001825034-2019-01414, 0001825034-2019-01416. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[140008076]
It was reported that a patient underwent an initial knee procedure and three years after the procedure the patient was revised due to instability and loosening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-01415 |
| MDR Report Key | 8456334 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-27 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2015-05-27 |
| Date Added to Maude | 2019-03-27 |
| 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 | VANGUARD 360 KNEE STYSTEM OSSEOTI TIBIAL SLEEVE AUGMENT |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBH |
| Date Received | 2019-03-27 |
| Model Number | N/A |
| Catalog Number | 185551 |
| Lot Number | 058470 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-27 |