MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2020-03-26 for POLARSTEM CEMENTLESS STEM STD TI.HA 4 75100467 manufactured by Smith & Nephew Orthopaedics Ag.
[186527763]
It was reported that the clinical subject presented a calcar fracture. This fracture was discovered after the surgery upon checking x rays. The event is being attributed to the implanting of the stem. The fracture was treated via cerclage wire. The subject is recovering positively and the implant is more stable than before.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613369-2020-00073 |
| MDR Report Key | 9885099 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2018-11-28 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2018-09-03 |
| Date Added to Maude | 2020-03-26 |
| 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 | POLARSTEM CEMENTLESS STEM STD TI.HA 4 |
| Generic Name | PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT |
| Product Code | LZO |
| Date Received | 2020-03-26 |
| Model Number | 75100467 |
| Catalog Number | 75100467 |
| Lot Number | B1804516 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW ORTHOPAEDICS AG |
| Manufacturer Address | SCHACHENALLEE 29 BAAR 06340 SZ 06340 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-26 |