MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-16 for COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN AE-QAS-K521-99 manufactured by Aesculap Implant Systems.
[48518791]
Country of complaint: (b)(6) on 05/19/2016 basic information was received regarding 1 year post operative breakage of a knee prosthesis. There was no information received regarding the involved product number, therefore the collective product code was used which gives reference to the potentially involved system. Information is being requested and update of this report will be made when received. *it should be noted that the product code selected is being selected in order to fulfill the requirements of this form and may not be the actual product code; the type of knee prosthesis involved is unknown. It is not possible to verify the product code.
Patient Sequence No: 1, Text Type: D, B5
[74515668]
Investigation: due to the circumstance that we did not receive the implants, an investigation is not possible. Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers. The device history file has been checked and found to be according to our specifications valid at the time of production. No similar incidents have been filed with products from these batches. This is the first case describing femoral stem fracture. Conclusion and root cause: a definitive conclusion and root cause could not be determined because an investigation was not possible. On the basis of the x-ray pictures, neither a fractured stem nor a failure of the enduro system can be determined. A possible root cause could be that the patient's bone situation was not optimal. In such cases the fixation between the implant and the bone might not be sufficient and it may not ossify. No capa is necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005673311-2016-00093 |
| MDR Report Key | 5730958 |
| Date Received | 2016-06-16 |
| Date of Report | 2017-04-04 |
| Date Facility Aware | 2016-06-07 |
| Date Mfgr Received | 2016-05-19 |
| Date Added to Maude | 2016-06-16 |
| 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 IMPL.MISC./UNKNOWN |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HSA |
| Date Received | 2016-06-16 |
| Model Number | AE-QAS-K521-99 |
| Catalog Number | AE-QAS-K521-99 |
| Device Availability | * |
| 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 | 2016-06-16 |