MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM G; PROSTHESIS, HIP

Model Number N/A

Device Problems Positioning Failure (1158); Packaging Problem (3007)

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

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 010000666-g7, pps ltd acet shell 58g-unknown.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 g7 liner would not seat properly.There was no patient harm or delay in procedure.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.Product has been returned without the packaging materials.Visual inspection of the returned product identified that the device is still sealed inside the poly pouch with no damage.Complaint could not be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.The device has been manufactured using the correct material and work instructions, however, it has been identified that there is a potential issue with the tyvek lid supplied.The root cause of the reported issue is attributed to manufacturing deficiency at the supplier of tyvek lids.Ie-11483 has also been raised to evaluate the risk control measures implemented by the manufacturer of the tyvek lids.Scar-02737 has been initiated to further address the reported supplier issue.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.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported, upon opening the package in the sterile field the paper stuck to the glue on the package and compromised sterility of contents.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: G7 NEUTRAL E1 LINER 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10313577
• MDR Text Key: 200042577
• Report Number: 0001825034-2020-02886
• 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,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2020

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 Model Number: N/A
• Device Catalogue Number: 010000859
• Device Lot Number: 6579229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 10/14/2020; 10/27/2020
• Supplement Dates FDA Received: 10/22/2020; 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10