MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-04-02 for UNKNOWN HUMERAL STEM N/A manufactured by Zimmer Biomet, Inc..
[140668545]
(b)(4). Udi # n/a. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2019 -01389. Patient not revised.
Patient Sequence No: 1, Text Type: N, H10
[140668546]
It was reported patient has been indicated for elbow revision due to unknown reasons. No revision has been reported to date.? Attempts to obtain additional information have been made; however, no more is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2019-01390 |
| MDR Report Key | 8475125 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-04-02 |
| Date of Report | 2019-07-10 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-07-03 |
| Date Added to Maude | 2019-04-02 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN HUMERAL STEM |
| Generic Name | ELBOW, PROSTHESIS |
| Product Code | JDB |
| Date Received | 2019-04-02 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2019-04-02 |