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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 12/08/2020

Event Type  Injury  

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 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.

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 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
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11146917
• MDR Text Key: 226020840
• Report Number: 0001825034-2021-00025
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00880304456648
• UDI-Public: (01)00880304456648(11)180514(10)287480
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention