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 PLASMACUP SC SIZE 52MM NH052T manufactured by Aesculap Ag.
[183944071]
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
[183944072]
It was reported that there was an issue with plasmacup. According to the complaint description, the patient had a post operative fracture of the ceramic insert. The initial surgery was on (b)(6) 2009. On (b)(6) 2020 the patient consulted the surgeon, because she heard a noise which was audible from the prosthesis; she also had complaints of discomfort. An x-ray examination revealed fragments of ceramic insert in the trochanter. The surgeon stated that anteversion of the acetabular is a bit increased, but it was not a problem. A revision surgery was necessary, but not yet scheduled. Additional information was not provided nor available / was not available. The adverse event/malfunction is filed under (b)(4). ( involved component). Associated medwatch-reports: (b)(4) nh103 is not reportable, because it is not approved in the us. Associated medwatch-reports with involved components: this reporting is only with involved components. We have no leading material. (b)(4)- biolox prosthesis head 12/14 32mm m - 51481241 (9610612-2020-00052).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00053 |
| MDR Report Key | 9847870 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2009-06-25 |
| 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 | PLASMACUP SC SIZE 52MM |
| Generic Name | HIP ENDOPROSTHETICS |
| Product Code | LWJ |
| Date Received | 2020-03-18 |
| Model Number | NH052T |
| Catalog Number | NH052T |
| Lot Number | 51572087 |
| 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 | 2020-03-18 |