MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-13 for DEPUY/CMW 2G 5450-32-500 545032500 manufactured by Depuy Cmw - 9610921.
[183544030]
(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
[183544031]
The patient presented for post-primary evaluations of the left knee on (b)(6) 2018 and (b)(6) 2018. The patient complained of pain, "snapping, cracking, and popping" of the knee, swelling, and stiffness. X-ray images showed the components to be intact, aligned, and with no fractures. The physician indicated he suspected tibial tray loosening. There is no evidence of revision or intervention. Three depuy cement products were used during the primary operation. Doi: (b)(6) 2016. Doe: (b)(6) 2018. Left knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07805 |
| MDR Report Key | 9830175 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-13 |
| Date of Report | 2019-10-09 |
| Date of Event | 2019-01-19 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2016-08-04 |
| Date Added to Maude | 2020-03-13 |
| 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 | DEPUY/CMW 2G |
| Generic Name | BONE CEMENT : BONE CEMENT |
| Product Code | MBB |
| Date Received | 2020-03-13 |
| Model Number | 5450-32-500 |
| Catalog Number | 545032500 |
| Lot Number | 8312417 |
| Device Expiration Date | 2019-04-30 |
| 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 | 2020-03-13 |