MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAESTRO RAD W/BRG 7X15 7.5 RT; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.
Event or Problem Description
It was reported that the patient is scheduled to be getting a revision due to the radial stem being loose in the canal.

• Brand Name: MAESTRO RAD W/BRG 7X15 7.5 RT
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9370562
• Report Number: 0001825034-2019-05314
• Device Sequence Number: 14130425
• Product Code: JWJ
• UDI-Device Identifier: 00880304439092
• UDI-Public: (01)00880304439092
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2020
• Device Model Number: N/A
• Device Catalogue Number: 180151
• Device Lot Number: 922440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention