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 2018-10-03 for E1 44-36 STD +3 HMRL BRG N/A EP-115394 manufactured by Zimmer Biomet, Inc..
[122531657]
(b)(4). Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined. Unique identifier (udi) #: (b)(4). Concomitant medical products: item # unk, baseplate, lot # unk. Item # unk, humeral stem, lot # unk. Item # unk, humeral tray, lot # unk. Item # unk, glenosphere, lot # unk.
Patient Sequence No: 1, Text Type: N, H10
[122531658]
It was reported that approximately 2 weeks post right shoulder arthroplasty, the patient had presented with a loose feeling and was found to have a dislocation. A revision procedure was performed, in which the surgeon found that the surrounding soft tissue was failing to keep the shoulder stable. The humeral bearing was revised. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09073 |
| MDR Report Key | 7931085 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-03 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-09-06 |
| Date Added to Maude | 2018-10-03 |
| 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 | E1 44-36 STD +3 HMRL BRG |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-10-03 |
| Model Number | N/A |
| Catalog Number | EP-115394 |
| Lot Number | UNK |
| 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 | 2018-10-03 |