MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-03 for 3D KNEE 391-09-706 manufactured by Encore Medical L.p..
[181784395]
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Patient Sequence No: 1, Text Type: N, H10
[181784396]
Revision surgery - the patient's knee became unstable and a thicker insert needed to be inserted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644408-2020-00150 |
| MDR Report Key | 9779827 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-03 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-06-25 |
| Date Added to Maude | 2020-03-03 |
| 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 | TEFFANY HUTTO |
| Manufacturer Street | 9800 METRIC BLVD |
| Manufacturer City | AUSTIN, TX 78758-5445, |
| Manufacturer Country | US |
| Manufacturer G1 | ENCORE MEDICAL L.P. |
| Manufacturer Street | 9800 METRIC BLVD |
| Manufacturer City | AUSTIN, TX 78758-5445, |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3D KNEE |
| Generic Name | INSERT, 3D EX SZ 6LT 9MM |
| Product Code | OIY |
| Date Received | 2020-03-03 |
| Model Number | 391-09-706 |
| Catalog Number | 391-09-706 |
| Lot Number | 283G1985 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENCORE MEDICAL L.P. |
| Manufacturer Address | 9800 METRIC BLVD AUSTIN, TX 78758-5445, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |