MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM INSERTER; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: unknown, reverse tray, lot # unknown; catalog #: 113627, comp primary stem 7mm mini mini, lot # 488500.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04382.
Event or Problem Description
It was reported that during a comprehensive reverse total shoulder procedure a humeral stem could not be attached to the inserter.The stem was inserted by hand, and then the humeral tray would not engage the stem.The stem was then removed.Additional broaching was required and a larger size stem was used to complete the procedure.
Additional Manufacturer Narrative
(b)(4).Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.

• Brand Name: COMP PRIMARY STEM INSERTER
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11146917
• Report Number: 0001825034-2021-00025
• Device Sequence Number: 3286060
• Product Code: LXH
• UDI-Device Identifier: 00880304456648
• UDI-Public: (01)00880304456648(11)180514(10)287480
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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 Model Number: N/A
• Device Catalogue Number: 407398
• Device Lot Number: 287480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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: Other; Required Intervention