MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-20 for R3 36MM ID US CRMC LINER 54 71338954 manufactured by Smith & Nephew, Inc..
[184333186]
It was reported that the biolox forte ceramic liner was broken. A revision surgery was performed to remove this device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00980 |
| MDR Report Key | 9861827 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-08-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2009-06-30 |
| Date Added to Maude | 2020-03-20 |
| 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 | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| 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 36MM ID US CRMC LINER 54 |
| Generic Name | PRSTHSIS,HIP,SMICONSTRAIND,MTAL/CRMIC/CRMIC/MTL,CMNTED OR UNCEMENTED |
| Product Code | MRA |
| Date Received | 2020-03-20 |
| Model Number | 71338954 |
| Catalog Number | 71338954 |
| Lot Number | 09FT32751 |
| Device Expiration Date | 2019-06-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-20 |