MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEU +5MM E1 LINER 36MM D D; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 01/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: 110017218-g7 neu+5mm e1 liner 36mm d d-6715159 unknown-unknown g7 cup-unknown multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00264.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a g7 cup was placed in patient and trial liners were used.It was determined the best option would be a plus 5 liner for the patient.An attempt was made to implant and engage the liner to the cup.There was no success.The cup was cleaned and tissue removed and impaction was attempted again.This liner would not engage and lock.Another liner was requested and attempted.This did not work either.The procedure was then changed to a dual mobility liner and the case was completed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies 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: G7 NEU +5MM E1 LINER 36MM D D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11236351
• MDR Text Key: 230742285
• Report Number: 0001825034-2021-00206
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K142882
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• 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: 110017218
• Device Lot Number: 6715159
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10