MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-05-07 for COMPREHENSIVE REVERSE E1 44-36 STD +3 HUMERAL BEARING N/A EP-115394 manufactured by Zimmer Biomet, Inc..
[107702683]
(b)(4). Concomitant medical products: 115370, comp rvs tray co 44mm, 577860. Product has been received by zimmer biomet and 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: 0001825034 - 2018 - 03204.
Patient Sequence No: 1, Text Type: N, H10
[107702684]
It was reported that during a reverse total shoulder arthroplasty, the humeral polyethylene liner was unable to be seated into the humeral tray on the back table. New implants were opened and utilized to successfully complete the procedure. No patient consequences were reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-03205 |
| MDR Report Key | 7491566 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-05-07 |
| Date of Report | 2018-09-17 |
| Date of Event | 2016-08-30 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2018-05-07 |
| 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 | COMPREHENSIVE REVERSE E1 44-36 STD +3 HUMERAL BEARING |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-05-07 |
| Returned To Mfg | 2018-04-11 |
| Model Number | N/A |
| Catalog Number | EP-115394 |
| Lot Number | 339410 |
| ID Number | (01) 00880304543188 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2018-05-07 |