MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER BASEPLATE AND ADAPTOR; EXTREMITIES IMPLANTS

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: catalog #: 110031429, cr vivacit-e 40mm brng +3 ret, lot # 64653609.Catalog #: 110031406, mini tray +5mm cocr +6 offset, lot # 64873971.Catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # j7630298.H3: the device will not be returned to zimmer biomet.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a paraplegic patient underwent a revision procedure approximately 4 months post implantation of a tsa.The patient was doing overhead physical therapy at 5-10lb, when the glenopshere disassociated from the baseplate.Attempts have been made and there is no further information at this time.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER BASEPLATE AND ADAPTOR
• Type of Device: EXTREMITIES IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19019092
• MDR Text Key: 339104781
• Report Number: 0001825034-2024-00914
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000589
• Device Lot Number: 66100940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 111 KG