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 2020-03-11 for ISODUR PROSTHESIS HEAD 8/10 22.2MM M NJ112K manufactured by Aesculap Ag.
[183005594]
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
[183005595]
It was reported that there was an issue with isodur prosthesis head. 12 years post-operative dislocation. The initial surgery was a total hip arthroplasty. In february, the patient fell backward and had dislocation. According to the patient, she was having snapping sensation in the prosthesis for a few days before the dislocation. Revision surgery was scheduled by the surgeon, however, at this point of time, has not been decided when. The surgeon stated that there is likely topical wear in the pe insert and it may have led the femoral head to dislocate from the insert. A revision surgery was necessary. Additional information has been requested. The adverse event is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00054 |
| MDR Report Key | 9819509 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-11 |
| 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 | ISODUR PROSTHESIS HEAD 8/10 22.2MM M |
| Generic Name | HIP ENDOPROSTHESES - HEADS |
| Product Code | LWJ |
| Date Received | 2020-03-11 |
| Model Number | NJ112K |
| Catalog Number | NJ112K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-11 |