MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-25 for COMPREHENSIVE REVERSE VERSA-DIAL GLENOSPHERE STANDARD N/A 115310 manufactured by Zimmer Biomet, Inc..
[124977732]
(b)(4). Concomitant medical products: 010000589,comprehensive mini baseplate & taper adaptor, 926840; 115370,cobalt chrome standard humeral tray, 597170; xl-115363,arcomxl standard humeral bearing, 073050; 113631,comprehensive humeral stem? Mini, 950590. Therapy date - (b)(6) 2016. 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 - 09920, 0001825034 - 2018 - 09922, 0001825034 - 2018 - 09923, 0001825034 - 2018 - 09924. Patient not yet revised.
Patient Sequence No: 1, Text Type: N, H10
[124977733]
It has been reported that patient had initial comprehensive reverse shoulder arthroplasty. Four (4) months post initial surgery, patient had abscess on incision site. Six (6) months later, irrigation and debridement was performed where abscess was opened and cleaned and cultures were taken. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09921 |
| MDR Report Key | 8004594 |
| Report Source | CONSUMER |
| Date Received | 2018-10-25 |
| Date of Report | 2018-10-24 |
| Date Mfgr Received | 2018-09-28 |
| Device Manufacturer Date | 2015-07-06 |
| Date Added to Maude | 2018-10-25 |
| 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 VERSA-DIAL GLENOSPHERE STANDARD |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-10-25 |
| Model Number | N/A |
| Catalog Number | 115310 |
| Lot Number | 626240 |
| 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. Required No Informationntervention | 2018-10-25 |