MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-23 for SMARTSET MV 40G - EO 3122-040 3122040 manufactured by Depuy Cmw - 9610921.
[188394336]
(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188394337]
Patient was revised to address pain and loosening of the tibial base plate at the cement to implant interface. Unknown cement manufacturer was used. Surgeon took an x-ray of the knee where he could see loosening of the tibial. Intraoperatively, when removing the tibial base plate it came out very easily with no cement on the underside of the implant while the cement-bone interface remained sound. Doi: (b)(6) 2015. Dor: (b)(6) 2020; right knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-08938 |
| MDR Report Key | 9868388 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-01-06 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2014-10-06 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY CMW - 9610921 |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL FY4 4QQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | FY4 4QQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTSET MV 40G - EO |
| Generic Name | BONE CEMENT : BONE CEMENT |
| Product Code | LOD |
| Date Received | 2020-03-23 |
| Model Number | 3122-040 |
| Catalog Number | 3122040 |
| Lot Number | 7951049 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY CMW - 9610921 |
| Manufacturer Address | CORNFORD RD BLACKPOOL FY4 4QQ UK FY4 4QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |