MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 CURVED INSERTER THD SHAFT; PROSTHESIS, HIP

Model Number N/A

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2019

Event Type  malfunction  

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.Concomitant medical products: item number: 110010247, item name: g7 osseoti shell, lot #: 6382348.Foreign report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03408.

Event Description

It was reported that the acetabular shell detached from the shell inserter during impaction.A different shell was used to complete the case.No patient harm was indicated.No additional information is available at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed with product return.Visual inspection of the inserter identified damages to the threads.The shell shows damage around the square locking feature and also damage to the threads.These damages were likely during an attempt to impact the inserter with the shell.It is unknown how many times the device was used.Review of the device history records identified no related deviations or anomalies during manufacturing.The damages suggest that the inserter was likely malaligned during the procedure; however a definitive root cause cannot 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: G7 CURVED INSERTER THD SHAFT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8855698
• MDR Text Key: 153132478
• Report Number: 0001825034-2019-03406
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110003454
• Device Lot Number: 400998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1