MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-13 for 3D KNEE 391-09-710 manufactured by Encore Medical L.p..
[174841822]
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
[174841823]
Revision surgery, patient had infection.
Patient Sequence No: 1, Text Type: D, B5
[186453146]
The reason for this revision surgery was reported as an infection. The previous revision surgery and the revision surgery detailed in this event occurred 3. 3 years apart. Initial or prolonged hospitalization was required. The healthcare professional indicated there was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device was disposed of at hospital and not made available to djo surgical for examination. A review of the device history record (dhr) show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements. There was no non-conforming material reports (ncmr) associated with the product that may have contributed to the reported event. The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review. The root cause of this complaint was a revision surgery due to an infection. There were no findings during this evaluation that indicate that the reported device was the source or had a direct connection with the patient's infection. No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system. There are multiple factors that may contribute to an infection that are outside the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644408-2019-01309 |
| MDR Report Key | 9581584 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-13 |
| Date of Report | 2020-02-11 |
| Date of Event | 2019-12-15 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2016-03-18 |
| Date Added to Maude | 2020-01-13 |
| 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 10LT 9MM |
| Product Code | OIY |
| Date Received | 2020-01-13 |
| Model Number | 391-09-710 |
| Catalog Number | 391-09-710 |
| Lot Number | 286G1927 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-13 |