MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-19 for COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE AE-QAS-K521-55 manufactured by Aesculap Ag.
[139290458]
(b)(4). Implant date: unknown. When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[139290459]
It was reported by the healthcare professional "patient had an enduro implanted, presented with joint pain and stiffness, was examined in clinic and determine an exploratory washout was necessary. Intraoperative tissue samples were collected and sent for lab work - tissues had a blackened appearance. The underside of the patellar tendon and intercondylar box had the highest concentration of blackened tissue. No damage to any of the components was observed neither were there indications of loosening of the hinge mechanism. A thorough washout was performed and the wound closed. Surgeon awaiting lab results to determine treatment. Images from case are available. " this incident did not cause or contribute to serious injury or death or a delay in surgery. All medwatch submissions related are: 9610612-2019-00179.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00178 |
| MDR Report Key | 8434527 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-19 |
| Date of Report | 2019-06-04 |
| Date of Event | 2019-02-21 |
| Date Facility Aware | 2019-04-15 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2015-10-27 |
| Date Added to Maude | 2019-03-19 |
| 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. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| 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 ROTAT.HINGE |
| Generic Name | KNEE ENDOPROSTHESES |
| Product Code | OOG |
| Date Received | 2019-03-19 |
| Model Number | AE-QAS-K521-55 |
| Catalog Number | AE-QAS-K521-55 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-19 |