MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for AS VEGA PS FEMORAL COMP.CEMENTED F4N R NX029Z manufactured by Aesculap Ag.
[186211162]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[186211163]
It was reported that there was an issue with as vega ps femoral component. According to the complaint description it was reported that vega femur and tibial components were loose 2 years and 6 month post surgery. The doctor was able to pull them off the bone with his fingers only. Procedure: total knee arthroplasty (tka) devices won? T be returned for evaluation. The operative report was not available. The type of cement used was palacos r+g cement. The explant was sent to pathology after surgery. The received x-ray pictures were not in a readable format. Initial surgery date: (b)(6) 2017. Revision surgery: (b)(6) 2020. A revision surgery was necessary. The adverse event is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2020-00087 ((b)(4) + nx053z).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00086 |
| MDR Report Key | 9904376 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2017-06-22 |
| Date Added to Maude | 2020-03-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AS VEGA PS FEMORAL COMP.CEMENTED F4N R |
| Generic Name | KNEE ENDOPROSTHESES |
| Product Code | JWH |
| Date Received | 2020-03-31 |
| Model Number | NX029Z |
| Catalog Number | NX029Z |
| Lot Number | 52330189 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |