MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-05 for VITELENE INSERT E 32MM POST.WALL NV301E manufactured by Aesculap Ag.
[182312038]
General information: we received a complaint about one nv301e vitelline insert e 32mm post. Wall from the (b)(6). The complained device is available in a decontaminated condition for investigation. The following information was provided to us: due to luxation revision, it was recognized that the inlay was not jammed, it was rotatable. Consequences for the patient: post-operative medical intervention was necessary revision operation due to subluxation investigation: the components were examined visually and microscopically with the digital microscope vhx-5000 keyence eq. -nr. 2000024840. In regard of "inlay was rotatable in the cup": the provided inlay show no damages or other abnormalities. Furthermore the relevant dimensions were measured in the precision measurement room. Result: small dimensional deviations in the area of the cone. It must be kept in mind that the inlay was implanted for more than one year. Therefore it is not unusual that due to potential one-sided load, the inlay shows deformations, especially at the area of the cone. This is also mentioned in the measurement report. Furthermore it must be mentioned that the pe deforms due to high temperature during the cleaning/decontamination process. The other dimensions of the inlay are within the specified tolerances. Therefore we assume that the inlay was dimensionally accurate at delivery. In regard of luxation": the provided x-ray figures show no definitive hints to determine the root cause for the luxation. Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: in regard of "inlay was rotatable in the cup": based on the information available it is not possible to determine a definitive root cause for the failure. It could be possible that the failure is patient/usage related. In regard of luxation": based on the information available as well as a result of our investigation it is not possible to determine a definitive root cause for the failure. It could be possible that the failure is patient / usage related. Rationale: in regard of "inlay was rotatable in the cup": there are no hints for a material problem. According to the quality standard and dhr files a material defect and production error was not found. It could be possible that due to a high number of one-sided load to the inlay because of an unfavourable implantation situation of the cup, the inlay came loose. See also point investigation. Furthermore it could be possible that du to an individual patient situation an abnormal high load (one-sided load) to the inlay lead to the mentioned failure. In regard of luxation": there are no hints for a material problem. According to the quality standard and dhr files a material defect and production error was not found. It could be possible that due to a high number of one-sided load to the inlay because of an unfavourable implantation situation or an individual patient situation a luxation could occur (for example excessive load). It could be possible that both failure modes: "inlay was rotatable in the cup" and "luxation" are interlinked directly with one another. Corrective action: according to sop (b)(4) (corrective action & preventive action) a capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[182312039]
It was reported that there was an issue with vitelline insert. According to the customer description: due to luxation revision, it was recognized that the inlay was not jammed; it was found to be rotatable. The revision was on (b)(6) 2020. Implantation: (b)(6) 2018. The first revision was on (b)(6) 2018. A revision surgery was necessary. Additional information was not provided nor available / was not available. Additional patient information is not available. The adverse event is filed under (b)(4). Involved components: nk560 - biolox prosthesis head 12/14 32mm s - 500481436. Nu208t - excia t plasmapore 12/14 size 8mm - 500481437. Nv248t - plasmafit plus 3 cup size 48mm e - unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00035 |
| MDR Report Key | 9794543 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2017-02-09 |
| Date Added to Maude | 2020-03-05 |
| 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 | VITELENE INSERT E 32MM POST.WALL |
| Generic Name | HIP ENDOPROSTHETICS |
| Product Code | OQG |
| Date Received | 2020-03-05 |
| Returned To Mfg | 2020-02-17 |
| Model Number | NV301E |
| Catalog Number | NV301E |
| Lot Number | 52298025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-05 |