MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 40MM I; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product(s): a 110010271, g7 osseoti multihole 66mm i, 6002522; 010000750, g7 neutral arcomxl lnr 40mm i, 6155078; 010000997, g7 screw 6.5mm x 20mm, 6182549; 010001001, g7 screw 6.5mm x 40mm, 3879260.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08154, 0001825034-2018-08155.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 was reported that the two g7 40mm liners were not seating into the g 7 cup but rather would toggle back and forth.The screws were fully seated.The procedure was completed with another product.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection found the rim of the shell to be slightly scuffed, scratched, and dinged.Scratching was also found near the apex of the shell's inner radius.Damage to the barb and outer radius of the liner were found during visual inspection of the liners.The barb has been roughened such that a poly strand protrudes from the liner in 2 locations.The outer radius is pitted.The rim of the liner is also gouged.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.

Event Description

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

• Brand Name: G7 HI-WALL ARCOMXL LNR 40MM I
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7798830
• MDR Text Key: 117705298
• Report Number: 0001825034-2018-08156
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000828
• Device Lot Number: 3955787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1