MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-14 for SUBCHONDROPLASTY N/A UNKNOWN manufactured by Zimmer Knee Creations, Inc..
[178109633]
On (b)(6) 2019, zimmer knee creations was notified of a patient reported adverse event via report number mw5091273. A patient underwent an initial subchondroplasty procedure on (b)(6) 2019, and then reported to have pain an complete loss of feeling in their knee and could not walk after surgery with an unknown onset date. The patient returned on an unknown date to a health care professional's office, where radiographic images were taken, and it was determined that the accufill implant had migrated outside of the bone. On an unknown date, the patient returned to surgery to remove the accufill. The product was not returned for the investigation. The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed. Once additional information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[178109694]
Patient reports pain and extravasation in knee after scp procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2020-00003 |
| MDR Report Key | 9587666 |
| Report Source | CONSUMER |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-02-21 |
| Date Facility Aware | 2019-12-11 |
| Report Date | 2019-11-22 |
| Date Reported to FDA | 2019-11-22 |
| Date Mfgr Received | 2019-12-11 |
| Date Added to Maude | 2020-01-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2020-01-14 |
| 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 | 2020-01-14 |