MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-12-23 for R3 0 DEG XLPE ACET LNR 36MM X MM56 71332756 manufactured by Smith & Nephew, Inc..
[172579975]
It was reported that the patient has a polarstem device in place since 2017 and was experiencing elevated cobalt levels. Revision surgery was performed and the poly was explanted and an oxiniu head was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2019-04570 |
| MDR Report Key | 9513573 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-12-23 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2014-12-16 |
| Date Added to Maude | 2019-12-23 |
| 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 | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | R3 0 DEG XLPE ACET LNR 36MM X MM56 |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL POROUS |
| Product Code | MBL |
| Date Received | 2019-12-23 |
| Model Number | 71332756 |
| Catalog Number | 71332756 |
| Lot Number | 14MM12431 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-23 |