MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FRDM CONST E1 10DEG LNR 36E; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the surgeon attempted to use a freedom liner on the patient.After several attempts of the liner not seating, the surgeon chose to use a dual mobility liner instead of the freedom liner.No adverse events have been reported as a result of the malfunction.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.D4: udi#:(b)(4) the following sections were updated/corrected updated: b4, b5, d4, g4, g7, h2, h3, h4, h6, h10 the event was confirmed with product received.Visual inspection found the ring and side of the liner to be heavily scratched.The barb and rim are both deformed.Dhr was reviewed and no discrepancies relevant to the reported event 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.

Event Description

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

• Brand Name: G7 FRDM CONST E1 10DEG LNR 36E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9930783
• MDR Text Key: 186749968
• Report Number: 0001825034-2020-01427
• Device Sequence Number: 1
• Product Code: OQI
• Combination Product (y/n): N
• PMA/PMN Number: K142882
• 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: 07/31/2020

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 Expiration Date: 12/17/2020
• Device Model Number: N/A
• Device Catalogue Number: 110010282
• Device Lot Number: 3704507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP