MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for APEX KNEE KC-36034 manufactured by Omnilife Science Inc..
[186283860]
The complainant made no indication of any omnilife science device malfunction or deficiency related to the identity, quality, durability, reliability, safety, effectiveness or device performance contributing to the adverse event. Review of the manufacturing documentation and sterilization documentation for the devices in question revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.
Patient Sequence No: 1, Text Type: N, H10
[186283861]
A complaint was initiated for a patient who underwent a knee revision surgery on (b)(6)2020. The original surgery date is (b)(6) 2016. The reason for revision is reported infection. During the revision, the tibial insert and femoral component were revised and replaced with new components.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226188-2020-00067 |
| MDR Report Key | 9907825 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-26 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2015-08-01 |
| Date Added to Maude | 2020-03-31 |
| 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 | DIANE MOORE |
| Manufacturer Street | 480 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 8242444 |
| Manufacturer G1 | OMNILIFE SCIENCE INC. |
| Manufacturer Street | 480 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APEX KNEE |
| Generic Name | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL |
| Product Code | JWH |
| Date Received | 2020-03-31 |
| Model Number | KC-36034 |
| Catalog Number | KC-36034 |
| Lot Number | 21469 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMNILIFE SCIENCE INC. |
| Manufacturer Address | 480 PARAMOUNT DR. RAYNHAM, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |