MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-29 for UNKNOWN BONE CEMENT UNK CEMENT manufactured by Depuy Cmw - 9610921.
[185915325]
(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
[185915326]
It as reported that the patient came to first follow up visit with significant lack of extension. Brought to or for manipulation vs revision. Full extension was not achievable closed while flexion was quite good. Medial repair had been disrupted when opened. Insert was removed and posterior release performed. Trials were placed and surgeon noted significant laxity on the medial side especially in flexion. A full revision was performed utilizing a hinged prosthesis. The lateral side was still very tight even after releasing the all collateral structures. The it band was then addressed multiple times in an attempt to have a more balanced knee. Cement was depuy, but specifics are unavailable due to hospital owning. Doi: (b)(6) 2020, dor: (b)(6) 2020, right knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09549 |
| MDR Report Key | 9896240 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | UNKNOWN BONE CEMENT |
| Generic Name | BONE CEMENT |
| Product Code | LOD |
| Date Received | 2020-03-29 |
| Catalog Number | UNK CEMENT |
| 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 | 2020-03-29 |