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 2019-11-25 for MAESTRO RAD W/BRG 7X15 7.5 RT N/A 180151 manufactured by Zimmer Biomet, Inc..
[167838112]
(b)(4). Concomitant medical products: catalog #: 180180, maestro radial stem 4. 5x40mm, lot # 181430, 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 # 238690n 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. Reported event was considered confirmed due to the proved x-rays that showed loosening of the radial component. Device history record was reviewed and no discrepancies relevant to the reported event were found. Root cause was considered to be user error as it was known that the patient was a nurse that lifted patients. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04291.
Patient Sequence No: 1, Text Type: N, H10
[167838113]
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 | 0001825034-2019-05314 |
| MDR Report Key | 9370562 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-25 |
| Date Mfgr Received | 2019-11-18 |
| Device Manufacturer Date | 2015-10-02 |
| Date Added to Maude | 2019-11-25 |
| 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 | MAESTRO RAD W/BRG 7X15 7.5 RT |
| Generic Name | PROSTHESIS SHOULDER |
| Product Code | JWJ |
| Date Received | 2019-11-25 |
| Model Number | N/A |
| Catalog Number | 180151 |
| Lot Number | 922440 |
| 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 | 2019-11-25 |