MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE GLENOID INSTRUMENTATION 4MM HYBRID GLENOID TRIAL; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It has been reported that during surgery, the tip on the glenoid trial broke while doctor was trialing.The broken piece was retrieved from the patient's body upon trial completion.No additional patient consequences were reported.

Event Description

It has been reported that during surgery, the tip on the glenoid trial broke while doctor was trialing.The broken piece was retrieved from the patient's body upon trial completion.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of products returned.Visual inspection showed wear and tear marks from use on the glenoid.Fracture of the central post was confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.

• Brand Name: COMPREHENSIVE GLENOID INSTRUMENTATION 4MM HYBRID GLENOID TRIAL
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7953192
• MDR Text Key: 123285307
• Report Number: 0001825034-2018-09605
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 406194
• Device Lot Number: 141970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention