MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-03-06 for UNKNOWN ULNA STEM NI manufactured by Zimmer Biomet, Inc..
[182338490]
(b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdrs are associated with this event. Please see associated reports: 0001822565 - 2020 - 00786.
Patient Sequence No: 1, Text Type: N, H10
[182338493]
It was reported that a patient underwent an elbow arthroplasty approximately 10 years ago. The patient is being indicated for a revision due to alleged implant failure and possible implant fracture; however, no revision procedure has been reported to date. Attempts have been made and additional information is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-00778 |
| MDR Report Key | 9797742 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-03-19 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ULNA STEM |
| Generic Name | PROSTHESIS, ELBOW |
| Product Code | JDB |
| Date Received | 2020-03-06 |
| Model Number | NI |
| 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. Other | 2020-03-06 |