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 2019-10-22 for SUBCHONDROPLASTY N/A UNKNOWN manufactured by Zimmer Knee Creations, Inc..
[163193338]
On (b)(6), 2017, a patient underwent an initial subchondroplasty procedure. On (b)(6) 2019, zimmer knee creations became aware of the adverse event of osteoarthritis which resulted in a total knee replacement of the left knee that occurred on (b)(6) 2019. The health care professional assessed the event and determined it was possible related to the subchondroplasty study procedure and not related the accufill implant. The operative notes for the event were requested from the clinical project lead. The product was not returned for the investigation, as it remains implanted in the patient. The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[163193339]
Subject (b)(4) adverse event of total knee replacement after scp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2019-00050 |
| MDR Report Key | 9217791 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-22 |
| Date of Report | 2019-10-21 |
| Date of Event | 2019-06-19 |
| Date Facility Aware | 2019-09-25 |
| Date Mfgr Received | 2019-09-25 |
| Date Added to Maude | 2019-10-22 |
| 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 | MR. LEO MUNAR |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4848794553 |
| Manufacturer G1 | ZIMMER KNEE CREATIONS, INC. |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBCHONDROPLASTY |
| Generic Name | SCP KIT |
| Product Code | OJH |
| Date Received | 2019-10-22 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER KNEE CREATIONS, INC. |
| Manufacturer Address | 841 SPRINGDALE DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-22 |