MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-01-15 for COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS AE-QAS-K521-53 manufactured by Aesculap Ag.
[175678082]
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
[175678083]
It was reported that there was an issue with knee implants, columbus system. The following information was reported: the incident occurred on (b)(6) 2019. There was a revision of columbus as primary knee. The reason for the revision surgery was because the patient was experiencing pain, and there was no clear reason as to the reason for the pain. The x-ray results showed alignment and the implant was not loose. The patient condition after surgery was noted to be excellent. The operative report and additional patient information is not available. The adverse event is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00004 |
| MDR Report Key | 9594198 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-15 |
| Date of Report | 2020-02-18 |
| Date of Event | 2019-12-16 |
| Date Facility Aware | 2020-01-24 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-15 |
| 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 | COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS |
| Generic Name | PREVIOUSLY REPORTED |
| Product Code | OOG |
| Date Received | 2020-01-15 |
| Model Number | AE-QAS-K521-53 |
| Catalog Number | AE-QAS-K521-53 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-15 |