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 2019-09-27 for MAESTRO RADIAL STEM 4.5X40MM N/A 180180 manufactured by Zimmer Biomet, Inc..
[165315140]
(b)(4). (udi): n/a. Medical product: catalog #: 180151, maestro rad w/brg 7x15 7. 5 rt, lot # 922440; catalog #: 180351, variable lock screw 4. 75x20mm, lot # 748570; catalog #: 180363, maestro tc carpalhd 7x15mm std, lot # 527190; catalog #: 180352, variable lock screw 4. 75x25mm, lot # 551330; catalog #: 180363, maestro tc carpalhd 7x15mm std, lot # 527190; catalog #: 180321, maestro tc capitatestem 6x15mm, lot # 238690. The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not. Once this information is obtained a follow-up mdr will be submitted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Unknown if product will be returned.
Patient Sequence No: 1, Text Type: N, H10
[165315141]
It was reported that the patient is scheduled to be getting a revision due to the radial stem being loose in the canal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-04291 |
| MDR Report Key | 9130210 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-09-27 |
| Date of Report | 2019-11-25 |
| Date Mfgr Received | 2019-11-06 |
| Date Added to Maude | 2019-09-27 |
| 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAESTRO RADIAL STEM 4.5X40MM |
| Generic Name | PROSTHESIS SHOULDER |
| Product Code | JWJ |
| Date Received | 2019-09-27 |
| Model Number | N/A |
| Catalog Number | 180180 |
| Lot Number | 181430 |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-09-27 |