MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-13 for DEPUY/CMW 2G 5450-32-500 545032500 manufactured by Depuy Orthopaedics, Inc. 1818910.
[185608328]
(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
[185608329]
On (b)(6) 2015, the patient underwent total right knee arthroplasty due to degenerative joint disease. The patella was resurfaced. The surgeon reported no intraoperative complications. The patient was implanted with the depuy knee system and smartset bone cement x 3. On (b)(6) 2019, the patient underwent a right knee revision due to loosening of the tibial component, and pain. The surgeon reported the tibial component was grossly loose at the implant to cement interface. He noted the femoral component was revised. The patella was retained. The patient was implanted with a competitor system and there were no complications to the procedure. Doi: (b)(6) 2015; dor: (b)(6) 2019 (rt knee).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-01663 |
| MDR Report Key | 9583355 |
| Report Source | OTHER |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-02-23 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2014-07-31 |
| Date Added to Maude | 2020-01-13 |
| 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 | 2020-01-13 |
| Model Number | 5450-32-500 |
| Catalog Number | 545032500 |
| Lot Number | 7957560 |
| Device Expiration Date | 2017-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-13 |