MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 CURVED ACET SHELL INSERTER; PROSTHESIS, HIP

Catalog Number 110003453

Device Problem Difficult to Insert (1316)

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

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as product location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted concomitant medical products: item # 110010246/ g7 osseoti 4 hole shell/ lot # 6639380.

Event Description

It was reported that during the hip surgery, the surgeon had to continually tighten the cup as it continued to come loose when impacted with mallet.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.The following sections were updated/corrected updated: g4; h2; h3; h5; h6.Reportable event was unable to be confirmed due to limited information received from customer.Device history record (dhr) review was unable to performed as the lot number of the devise involved in the event is unknown, root cause was unable to 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 CURVED ACET SHELL INSERTER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9928941
• MDR Text Key: 186747964
• Report Number: 0001825034-2020-01468
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110003453
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10