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 2020-01-10 for SUBCHONDROPLASTY N/A UNK manufactured by Zimmer Knee Creations, Inc..
[174549641]
On (b)(6) 2016, the patient underwent an initial subchondroplasty procedure on their right knee. On (b)(6) 2019, the patient underwent a partial knee replacement of the right knee due the progression of osteoarthritis. The patient had a previous right knee scope performed on (b)(6) 2013. The health care professional reported that the event was not related to the subchondroplasty implant, but was possibly related to the procedure. The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed. The device in question was not returned, as it remains implanted in the patient. Once additional information about the event becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[174549642]
Subject (b)(6) experienced adverse event of osteoarthritis resulting in partial knee replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2020-00002 |
| MDR Report Key | 9576470 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-12-12 |
| Date Added to Maude | 2020-01-10 |
| 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 | 2020-01-10 |
| Model Number | N/A |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2020-01-10 |