MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-30 for DEPUY/CMW 2G 5450-32-500 545032500 manufactured by Depuy Cmw - 9610921.
[187783862]
Product complaint # (b)(4). Initial reporter occupation: lawyer. (b)(4). 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
[187783863]
Knee claim record received. Claim record alleges failed patellofemoral arthroplasty. Depuy cement was used. Primary operative notes (b)(6) 2016 indicate the patient received a right knee patella femoral arthroplasty due to patellofemoral arthritis. Revision operative notes (b)(6) 2018 indicate the patient received a right patella femoral knee revision with implantation of competitor right total knee due to failed patella femoral knee arthroplasty. Upon entering the joint, hypertrophic scarring is encountered along with osteophytes along the femoral component, scaring and osteophytes removed. The surgery was completed without indication of complication by the surgeon. Doi: (b)(6) 2016. Dor: (b)(6) 2018. Right knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-03559 |
| MDR Report Key | 9647343 |
| Report Source | OTHER |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-16 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2015-12-08 |
| Date Added to Maude | 2020-01-30 |
| 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 | 2020-01-30 |
| Model Number | 5450-32-500 |
| Catalog Number | 545032500 |
| Lot Number | 8205478 |
| Device Expiration Date | 2018-11-30 |
| 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 CMW - 9610921 |
| Manufacturer Address | CORNFORD RD BLACKPOOL FY4 4QQ UK FY4 4QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-30 |