MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-25 for DISCOVERY ELBOW 114909 manufactured by Encore Medical L.p..
[180832387]
The reason for this revision surgery was reported as loosening. Initial implant done approximately 5 yrs prior. The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established. 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. The revised item was not returned for examination and the lot number was not provided. To adequately investigate this event, the lot number was necessary. If this information is submitted at a future date, this investigation will be re-evaluated. The root cause of this complaint was a revision surgery due to loosening. There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event. This complaint will be closed pending receipt of additional information.
Patient Sequence No: 1, Text Type: N, H10
[180832388]
Revision surgery - revision of humeral component due to loose component. Initial implant done approximately 5 years prior.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644408-2020-00107 |
| MDR Report Key | 9750340 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-25 |
| 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 | DISCOVERY ELBOW |
| Generic Name | DISC HUM 6X100MM RT FLANGED C |
| Product Code | JDC |
| Date Received | 2020-02-25 |
| Catalog Number | 114909 |
| Lot Number | UNKNOWN |
| 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 | 2020-02-25 |