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 CPLT KNEE KIT 5CC 11G SIDE N/A 414.502 manufactured by Zimmer Knee Creations, Inc..
[161796629]
On (b)(6) 2019, subject 13-006 underwent an initial subchondroplasty procedure and a medial partial meniscectomy. Five cc's of accufill were implanted into the medial femoral chondyle and four cc's of accufill were implanted into the medial tibial plateau. Same part number and lot number were used for both lesions. During the procedure, extrusion of accufill into the knee joint during surgery was observed, most likely due to the accufill leaking through the medial femoral fissures, into the knee joint. The accufill fragments were removed with a shaver. The joint was thoroughly inspected to ensure no remaining fragments were present in the knee joint before closing. Zimmer knee creations was notified of the event on (b)(6) 2019. On the post-operative notes, it was noted that the patient was indicated as recovered. The device remains implanted and will not be returned for the investigation. Once additional information about the event becomes available, a supplemental report will be submitted. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[161796630]
13-006 had extrusion of accufill into the knee joint during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2019-00048 |
| MDR Report Key | 9174429 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-10 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-09-10 |
| Date Facility Aware | 2019-09-12 |
| Date Mfgr Received | 2019-09-12 |
| Device Manufacturer Date | 2018-08-31 |
| 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 | CPLT KNEE KIT 5CC 11G SIDE |
| Generic Name | SCP KIT |
| Product Code | OJH |
| Date Received | 2019-10-10 |
| Model Number | N/A |
| Catalog Number | 414.502 |
| Lot Number | KC05432 |
| 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 | 1. Other | 2019-10-10 |