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 2020-03-18 for METHA NECK 12/14 135?/0? NC088K manufactured by Aesculap Ag.
[184717044]
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
[184717045]
It was reported that there was an issue with metha neck. On (b)(6) 2009 the patient was advised to receive a surgery to treat the left hip coxarthrosis. On (b)(6) 2010 the same was advised for the right hip. Following both surgeries the patient suffered from unspecified "severe and permanent consequences", due to metallosis caused by the defective prosthesis. The patient was treated by a physician and revision(s) were performed. A revision surgery was necessary. Information about the involved products has been received, related to (b)(4) (nc088k/51555649). The adverse event/malfunction is filed under (b)(4). Associated medwatch-reports: 9610612-2020-00080 ((b)(4) nc082t). 9610612-2020-00081 ((b)(4)). 9610612-2020-00082 ((b)(4) nc082t). Same patient - involved component (b)(4), nc088k-51555649 (9610612-2019-00781).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00081 |
| MDR Report Key | 9849313 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-05-27 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2010-02-12 |
| Date Added to Maude | 2020-03-18 |
| 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 | METHA NECK 12/14 135?/0? |
| Generic Name | HIP ENDOPROSTHETICS |
| Product Code | LWJ |
| Date Received | 2020-03-18 |
| Model Number | NC088K |
| Catalog Number | NC088K |
| Lot Number | 51623012 |
| Device Expiration Date | 2019-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-18 |