MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for SMARTMIX BOWL 540180000 manufactured by Depuy Cmw 9610921.
[139696657]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139696658]
It was reported once that the same issue occurred intraoperatively (it? S reported as pc-(b)(4)). The multi pressure vacuum pump (p/n: 831401) and the air line (p/n: 3210031) were connected to the smart mix bowl empty (p/n: 540180000) and used for mixing the cement (manufactured by zimmer) during surgery (date of surgery was unknown). It was reported that bubbles were formed in the cement due to inadequate cement stirring. The surgery was completed and there was no adverse consequence to the patient. It was unknown whether there was a surgical delay or not. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-88161 |
| MDR Report Key | 8444038 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-04 |
| Date Mfgr Received | 2019-05-29 |
| Date Added to Maude | 2019-03-22 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 19380XXXX |
| Manufacturer Country | US |
| Manufacturer Postal | 19380XXXX |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY CMW- 9610921 |
| Manufacturer Street | CORNFORD RD. |
| Manufacturer City | BLACKPOOL IN FY4 4QQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | FY4 4QQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SMARTMIX BOWL |
| Generic Name | BONE CEMENT : CEMENT DELIVERY DEVICES |
| Product Code | KIH |
| Date Received | 2019-03-22 |
| Catalog Number | 540180000 |
| Lot Number | UNK |
| 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 FY44QQ UK FY44QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |