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 2020-03-04 for COLLECT.NO.QAS FEM.HEADS BIOLOX AE-QAS-H547-01 manufactured by Aesculap Ag.
[182307994]
Manufacturing site evaluation: we received a complaint about a broken ceramic ball head. According to the provided information, the ball head was implanted in the year 2000. No further information is available. We did not receive the broken ball head for investigation. Investigation: due to a lack of components, an investigation is not possible. Batch history review: due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete. Conclusion and root cause: the failure is most probably patient related. Rationale: due to the fact that we did not receive the components nor further information for an investigation, a clear conclusion can not be drawn. However, based on our experience we suspect that the root cause is most likely patient related (e. G. Due to overload) after this long amount of implantation time. Corrective action: a capa is not necessary according to sop (b)(4) (corrective action and preventive action).
Patient Sequence No: 1, Text Type: N, H10
[182307995]
It was reported that there was an issue with a ceramic femoral head. According to the reporter there was a fracture of the ceramic ball head 20-years postoperatively; with horizontal hip, total hip replacement (tep). A revision surgery was necessary. An additional medical intervention was necessary. Additional information was provided in form of preoperative x-rays, which did not show the fracture (before initial implantation). The adverse event is filed under aag reference (b)(4). Involved components: ae-qas-h547-01 - ollect. No. Qas fem. Heads biolox. Nk515t - bicontact s plasmapore 12/14 size 15mm - 51051901. Ae-qas-h548-01 - collect. No. Qas acetab. Cups biolox.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00030 |
| MDR Report Key | 9786221 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-05-05 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-03-04 |
| 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 | COLLECT.NO.QAS FEM.HEADS BIOLOX |
| Generic Name | HIP ENDOPROSTHESES - HEADS |
| Product Code | LWJ |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2020-03-02 |
| Model Number | AE-QAS-H547-01 |
| Catalog Number | AE-QAS-H547-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-04 |