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 2020-02-19 for SUBCHONDROPLASTY N/A 514.303 manufactured by Zimmer Knee Creations, Inc..
[187431666]
On (b)(6) 2020, a patient underwent a subchondroplasty procedure in an antegrade approach on their right talus. The talus was injected with 1. 0 cc accufill reconstituted with saline. It is unknown at this time if concomitant procedures were performed. The patient does have a medical history of gout. On (b)(6) 2020, the patient was hospitalized for increased pain and administration of pain medication. The health care professional determined the event was definitely related to the procedure and possible related to the implant. The redacted operative notes were provided for the investigation. Once additional information about the event becomes available, an additional report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[187431667]
Subject 12-024 suffers severe ankle pain after scp f&a study.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2020-00006 |
| MDR Report Key | 9728696 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-28 |
| Date Facility Aware | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-11-06 |
| Date Added to Maude | 2020-02-19 |
| 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 | 2020-02-19 |
| Model Number | N/A |
| Catalog Number | 514.303 |
| Lot Number | KC06404 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-19 |