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 2020-03-27 for UNK TAPER ADAPTER NI manufactured by Zimmer Biomet, Inc..
[186297826]
(b)(4). Concomitant medical products: unknown glenosphere, unknown humeral bearing, unknown humeral tray, unknown humeral stem, unknown base plate. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded. 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: 0001825034-2020-01328.
Patient Sequence No: 1, Text Type: N, H10
[186297827]
It has been reported patient underwent initial reverse shoulder arthroplasty. Subsequently patient was revised three (3) months post implantation due to disassociation of the glenosphere from base plate. Glenosphere and poly were revised. Attempts were made and no additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01327 |
| MDR Report Key | 9888805 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-27 |
| 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 | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK TAPER ADAPTER |
| Generic Name | PROSTHESIS, EXTREMITIES |
| Product Code | HSD |
| Date Received | 2020-03-27 |
| Model Number | NI |
| Catalog Number | UNK TAPER ADAPTER |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-27 |