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 2017-10-26 for UNKNOWN NEXEL PROXIMAL ULNA N/A manufactured by Zimmer Biomet, Inc..
[90341768]
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[90341769]
It was reported the patient is being considered for a revision to address unknown issue(s). No further information has been made available.
Patient Sequence No: 1, Text Type: D, B5
[113297609]
Upon reassessment of the reported event, it was determined to not be reportable as we do not have reporting responsibility for this complaint. The initial report was submitted in error and should be voided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001822565-2017-07441 |
| MDR Report Key | 6980301 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-10-26 |
| Date of Report | 2017-11-30 |
| Date Mfgr Received | 2017-11-02 |
| Date Added to Maude | 2017-10-26 |
| 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 NEXEL PROXIMAL ULNA |
| Generic Name | PROSTHESIS, EXTREMITY |
| Product Code | KXE |
| Date Received | 2017-10-26 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | N/A |
| Operator | PHYSICIAN |
| 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. Required No Informationntervention | 2017-10-26 |