MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-16 for HIGHLY CROSS-LINKED KNEE 392-09-706 manufactured by Encore Medical L.p..
[175373184]
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
[175373185]
Revision surgery - due to patient complaining of pain and instability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644408-2019-01345 |
| MDR Report Key | 9598145 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-16 |
| Date of Report | 2020-02-18 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2016-11-01 |
| Date Added to Maude | 2020-01-16 |
| 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, TX 787585445 |
| Manufacturer Country | US |
| Manufacturer Postal | 787585445 |
| Manufacturer G1 | ENCORE MEDICAL L.P. |
| Manufacturer Street | 9800 METRIC BLVD |
| Manufacturer City | AUSTIN, TX 78758-5445, TX 787585445 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 787585445 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGHLY CROSS-LINKED KNEE |
| Generic Name | INSERT, 3D EX SZ 6RT 9MM |
| Product Code | OIY |
| Date Received | 2020-01-16 |
| Model Number | 392-09-706 |
| Catalog Number | 392-09-706 |
| Lot Number | 328G1106 |
| 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, TX 787585445 US 787585445 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-16 |