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 2020-01-09 for SUBCHONDROPLASTY N/A 402.202 manufactured by Zimmer Knee Creations, Inc..
[174369104]
On (b)(6) 2019, a patient underwent a right knee scope with a subchondroplasty. There were no complications reported during the procedure; the patient had no other known pre-existing conditions that may have contributed to the event. The patient experienced increased pain following the subchondroplasty procedure and is in ambulating with crutches. He had follow-up mri which showed increased edema insitu, those images will be reviewed as a part of the investigation. The product was not returned for the investigation, as it remains implanted in the patient. Once additional information becomes available, a follow up report will be submitted. Implant remains in patient.
Patient Sequence No: 1, Text Type: N, H10
[174369105]
Patient has increased pain since (b)(6) 2019 scp and scope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2020-00001 |
| MDR Report Key | 9570678 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-08-07 |
| Date Facility Aware | 2019-12-10 |
| Date Mfgr Received | 2019-12-10 |
| Device Manufacturer Date | 2019-07-16 |
| Date Added to Maude | 2020-01-09 |
| 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 | 2020-01-09 |
| Model Number | N/A |
| Catalog Number | 402.202 |
| Lot Number | KC06211 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| 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 | 2020-01-09 |