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 2019-10-10 for SUBCHONDROPLASTY N/A 514.502 manufactured by Zimmer Knee Creations, Inc..
[161927349]
On (b)(6) 2019, a patient underwent a subchondroplasty procedure with no intraoperative complications reported. The patient was then sent to the post-anesthesia care unit, where the woke up normally. Within an hour, the patient began acting differently and was short of breath. A ct scan was taken and an embolus was noted in the patient's brain. Through an initial interview, the sales representative stated that the patient had experienced a stroke post-operatively. The investigation for this event in ongoing. Once additional information becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[161927350]
Patient acted differently and experienced shortness of breath after scp procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2019-00047 |
| MDR Report Key | 9175771 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-10 |
| Date of Report | 2019-10-07 |
| Date of Event | 2019-09-10 |
| Date Facility Aware | 2019-09-10 |
| Date Mfgr Received | 2019-09-10 |
| Device Manufacturer Date | 2018-09-05 |
| Date Added to Maude | 2019-10-10 |
| 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 | 2019-10-10 |
| Model Number | N/A |
| Catalog Number | 514.502 |
| Lot Number | KC05449 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| 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 | 2019-10-10 |