MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG E1 LINER 36MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000663 g7 shell 6613089 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.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2020-00777.

Event Description

It was reported that patient underwent a hip surgery the same day as an initial surgery and the surgeon continued to have difficulty seating the liner.A new liner and shell set was finally used to complete the surgery with no noted complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: 110010265 ¿ g7 multihole shell ¿ 6388729.Complaint sample was evaluated against the reported event.Visual inspection shows damage to the scallops and circular markings on the outside diameter.Dhr was reviewed and no discrepancies that would contribute to the reported event were found.The root cause is 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

It was reported that patient underwent a hip revision the same day as an initial surgery.During the revision, the shell component was replaced with a larger size and the surgeon still had difficulty inserting a liner.A second liner was finally able to be sat properly to complete the surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: G7 10 DEG E1 LINER 36MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9728087
• MDR Text Key: 205954150
• Report Number: 0001825034-2020-00775
• 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
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000897
• Device Lot Number: 6369893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10
• Patient Age: 61 YR