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 2018-12-27 for CERAMIC CERAMIC INSERT STANDARD 44/36 75007454 manufactured by Smith & Nephew Orthopaedics Ag.
[131544752]
Patient Sequence No: 1, Text Type: N, H10
[131544753]
It was reported a revision surgery due to breakage of the mpf insert. It is unknown if all components were explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2018-02914 |
| MDR Report Key | 8200584 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2008-11-10 |
| Date Added to Maude | 2018-12-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. SARAH FREESTONE |
| Manufacturer Street | OBERNEUHOFSTRASSE 10D |
| Manufacturer City | BAAR 06340 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 06340 |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW ORTHOPAEDICS AG |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU CH5000 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH5000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERAMIC CERAMIC INSERT STANDARD 44/36 |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC, CEMENTED |
| Product Code | LPF |
| Date Received | 2018-12-27 |
| Returned To Mfg | 2019-01-09 |
| Catalog Number | 75007454 |
| Lot Number | C0808146 |
| Device Expiration Date | 2015-11-09 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW ORTHOPAEDICS AG |
| Manufacturer Address | OBERNEUHOFSTRASSE 10D BAAR 06340 SZ 06340 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-12-27 |