MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-12-19 for COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS AE-QAS-K521-53 manufactured by Aesculap Implant Systems.
[95744414]
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned
Patient Sequence No: 1, Text Type: N, H10
[95744415]
Country of complaint: usa. The patient was in the shower and scrubbing her left knee (patient is a (b)(6) female). She heard a pop before the onset of pain. She then suffered a mechanical fall but was able to catch herself and denies any head trauma. She was reduced in the er under conscious sedation. The patient had problems walking and had to be reduced in the or after dislocating her knee (jumped post) while scrubbing her left leg in the shower. Patients knee dislocated on (b)(6) 2017 after a columbus revision tka was performed on (b)(6) 2017. There was injury to patient when dislocation occurred. No delay in surgery. X-rays were taken post op and after the dislocation. The revision surgery on (b)(6) 2017 however, the surgeon did not feel that an incident report/complaint was required. The surgeon completing the revision surgery is not the surgeon that initially implanted the device. He refused to provide information related to this incident other than the fact that he revised an aesculap knee. Surgeon feels that the issue of jumping off the post can result from many factors and does not allege a device deficiency. Issue reported by sales rep in order to document this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2017-00627 |
| MDR Report Key | 7130369 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-12-19 |
| Date of Report | 2018-02-26 |
| Date of Event | 2017-10-01 |
| Date Facility Aware | 2017-12-19 |
| Date Mfgr Received | 2017-10-02 |
| Date Added to Maude | 2017-12-19 |
| 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. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| 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 | AE-QAS-K521-53 |
| Product Code | OOG |
| Date Received | 2017-12-19 |
| 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 | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP IMPLANT SYSTEMS |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-12-19 |