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 2018-06-01 for UNKNOWN BASEPLATE N/A manufactured by Zimmer Biomet, Inc..
[109881185]
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 03754. Customer has not indicated that the product will be returned to zimmer biomet for investigation or not. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[109881186]
It was reported that patient underwent reverse shoulder arthroplasty combined with a latissimus dorsi tendon transfer. Subsequently patient was revised due to instability. During the revision, the baseplate was revised and the humeral poly was noted to be disassociated with medial wear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-03755 |
| MDR Report Key | 7562595 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-01 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-06-20 |
| Date Added to Maude | 2018-06-01 |
| 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 BASEPLATE |
| Generic Name | PROTHESIS, SHOULDER |
| Product Code | MJT |
| Date Received | 2018-06-01 |
| 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 | 2018-06-01 |