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 2020-03-10 for ISODUR PROSTHESIS HEAD 8/10 22.2MM M NJ112K manufactured by Aesculap Ag.
[183099899]
Associated medwatch-reports: 9610612-2020-00042 ((b)(4) nk022k). 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
[183099900]
It was reported that there was an issue with an isodur prosthesis head. On (b)(6) 2009, the patient underwent an initial bipolar hip arthroplasty procedure. On (b)(6) 2019, there was an emergent consultation due to dislocation of femoral head. X-ray results showed possible migration of the bipolar cup. Non-invasive repositioning of the femoral head was successfully performed. The patient was discharged the same day, but it was noted that there was still the possibility that the cup ring remained displaced. In addition, damage to the acetabulum was suspected. On (b)(6) 2020, a revision occurred. The bipolar cup and the femoral head were removed. The cup showed extreme wear, and the cup ring showed multiple dents, which likely occurred as a result of frequent neck impingement that was triggered by cup migration. The physician noted that the wear had occurred over a long period of time, and it had initially not been much of a concern. A revision surgery was necessary. An additional medical intervention was necessary. The adverse event is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2020-00042 ((b)(4) nk022k) - cup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00041 |
| MDR Report Key | 9813775 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2008-04-23 |
| Date Added to Maude | 2020-03-10 |
| 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 | 2020-03-10 |
| Model Number | NJ112K |
| Catalog Number | NJ112K |
| Lot Number | 51483576 |
| Device Expiration Date | 2018-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-10 |