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 |