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 TIBIAL PLATEAU CEMENTED T1 NX051Z manufactured by Aesculap Ag.
[186211276]
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
[186211277]
It was reported that there was an issue with as vega ps tibial plateau. According to the complaint description, the surgeon brought this patient into the operating room (or) due to pain and potential loose tibia after a total knee surgery. In surgery, it was found that the tibial implant was loose, and there had been no cement bonded to the implant. The outcome of the patient is currently unknown. Procedure: total knee arthroplasty (tka). Initial surgery date: (b)(6) 2017. The explant was sent to pathology after surgery. The type of cement used was palacos r+g cement. An x-ray result was received but format was not readable. A revision surgery was necessary. The adverse event is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00088 |
| MDR Report Key | 9904381 |
| 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 | 2016-09-16 |
| 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 TIBIAL PLATEAU CEMENTED T1 |
| Generic Name | KNEE ENDOPROSTHESES |
| Product Code | JWH |
| Date Received | 2020-03-31 |
| Model Number | NX051Z |
| Catalog Number | NX051Z |
| Lot Number | 52261022 |
| 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 |