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 2019-04-05 for ACCUPORT N/A 308.151 manufactured by Zimmer Knee Creations, Inc..
[141109017]
This is an adverse event for a clinical study subject in the (b)(6) study. Patient underwent scp in an antegrade approach on the left cuboid and navicular on (b)(6) 2018. The cuboid was injected with. 8 cc accufill? Reconstituted with saline. The navicular was injected with. 5 cc accufill reconstituted with saline. No concomitant procedures were performed. The patient presented with increased pain after the subchondroplasty procedure. Treatment provided was medications. The event was evaluated as moderate in intensity, probably procedure related and possibly related to the implant. This patient will continue to be monitored through their involvement in the study. At the time of this investigation and through the study documents, the surgeon has not indicated need for additional surgical intervention. This complaint is being closed recognizing that this patient will continue to be monitored through the study. If more information is made available this complaint will be reopened. The dhr for the finished goods lot was reviewed, and no anomalies related to the complaint condition were noted. The product was not returned for the investigation, as it remains implanted in the patient.
Patient Sequence No: 1, Text Type: N, H10
[141109018]
Clinical subject (b)(6) experienced increased pain after scp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2019-00021 |
| MDR Report Key | 8489025 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-05 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-03-21 |
| Device Manufacturer Date | 2018-05-01 |
| Date Added to Maude | 2019-04-05 |
| 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 | MS. SHARI BAILEY |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4848794543 |
| 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 | ACCUPORT |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2019-04-05 |
| Model Number | N/A |
| Catalog Number | 308.151 |
| Lot Number | 39976 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 11 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 | 2019-04-05 |