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 2020-03-12 for BIOLOX PROSTHESIS HEAD 12/14 32MM S NK560 manufactured by Aesculap Ag.
[183275117]
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
[183275118]
It was reported that there was an issue with biolox prosthesis head. It was reported that the patient is (b)(6) years old. The patient had after 12 years a post-operative dislocation. The date of the initial surgery is unknown. The batch number of the sample is unknown. The acetabular cup and insert are not aesculap products. Pre- revision tests showed no sign of loosening of the stem, and the dislocation was most likely due to chronic wear of the insert over time. The revision surgery was scheduled for 26th february, where the insert and the femoral head will be replaced. A revision surgery was necessary. Additional information was not provided nor available / was not available. The adverse event/malfunction is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00056 |
| MDR Report Key | 9824495 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-12 |
| 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 | BIOLOX PROSTHESIS HEAD 12/14 32MM S |
| Generic Name | HIP ENDOPROSTHETICS |
| Product Code | LWJ |
| Date Received | 2020-03-12 |
| Model Number | NK560 |
| Catalog Number | NK560 |
| 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 | 2020-03-12 |