MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-11 for VERSA-DIAL/COMP TI STD TAPER N/A 118001 manufactured by Zimmer Biomet, Inc..
[141584633]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi) #: (b)(4). Concomitant medical products: 115323, glenosphere, lot: 350070; xl-115367, humeral bearing, lot: 700020; 115370, tray, lot 874190. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01637.
Patient Sequence No: 1, Text Type: N, H10
[141584635]
It was reported that approximately 9 months post implantation, the patient was revised due to disassociation between the glenosphere and taper adaptor. Reportedly, the disassociation occurred after a fall. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-01638 |
| MDR Report Key | 8503475 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-11 |
| Date of Report | 2019-09-19 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-09-18 |
| Device Manufacturer Date | 2018-04-03 |
| Date Added to Maude | 2019-04-11 |
| 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 | VERSA-DIAL/COMP TI STD TAPER |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | MBF |
| Date Received | 2019-04-11 |
| Model Number | N/A |
| Catalog Number | 118001 |
| Lot Number | 808490 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-11 |