MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL ARCOMXL LINER; PROSTHESIS HIP

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Code Available (3191)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: g7 osseoti 4 hole shell, # item (b)(4), lot 6258567 unk femoral head, unk stem.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 surgeon was unable to get the liner to sit inside of the shell and lock.After several attempts to seat the liner, the shell loosened from the patients acetabulum.This took an additional 45 minutes to fix which resulted in longer or time.Attempts have been made and additional information on the reported event is unavailable.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Neutral arcom liner, was returned and evaluated against the complaint.The liner remains assembled with the shell.Scratching and gouging was observed on the rim and inner radius of the liner.The liner is held tight in the shell with no movement being allowed in any direction.The scallops of the liner are slightly deformed and protrude above the level of the shell.A dimensional analysis cannot be performed due to the impaction of the liner into the shell and its resulting damage.Shell was returned and evaluated against the complaint.The shell remains assembled with the liner.Scratching was observed on the rim of the shell.The 4 apical hole plugs and screw hole plug remain a part of the shell.No damage was observed to the outer radius of the shell.Dimensional analysis was performed 100% at time of manufacturing and no deviations were identified.Device history record 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 NEUTRAL ARCOMXL LINER
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7791118
• MDR Text Key: 117421539
• Report Number: 0001825034-2018-08112
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000741
• Device Lot Number: 6267946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR