MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 28MM A; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04931.

Event Description

It was reported that the liner would not assemble with the shell.The surgery was finished with backup product.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

This follow-up report is being submitted to relay additional information.Udi#: (b)(4).The event was confirmed with product returned.Visual examination of the returned liner identified circular indentations on the outer radius that are consistent with contact with a bone screw.Indentations were found in 2 locations with one location also having a second, smaller mark consistent with the opening in the head of the screw.Only micro scratches were observed on the barb.The scallops and remainder of liner are free from damage.A small blemish was seen at the apex of the outer radius which appeared to be made from contact with an object rather than a molding defect.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to the presence of screws impinging on the liner.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 E1 LINER 28MM A
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9273227
• MDR Text Key: 194390292
• Report Number: 0001825034-2019-04930
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000835
• Device Lot Number: 6363240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#:110010240 G7 SHELL LOT#:6267593