MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 44MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

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

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803203 femoral head sterile product 12/14 taper 63152918.00784301116 femoral stem beaded fullcoat 12/14 neck 62847466.Item# unknown unknown g7 cup lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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 reports: 0001825034-2020-00430.

Event Description

It was reported during a revision procedure, after the liner was placed, the surgeon was not able to get a small enough ceramic head size.Surgeon attempted to remove the new liner from the cup and the liner would not disengage from the cup.The cup and liner were removed and an addition cup and liner were implanted.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d11, g4, h2, h3, h6.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Revision op notes indicate that the surgeon was unable to get small enough ceramic head size.Surgeon attempted to remove the new liner from the cup and the liner would not disengage from the cup.The surgeon removed the cup and implanted new g7 shell with 40mm neutral 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.

Event Description

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

• Brand Name: G7 DUAL MOBILITY LINER 44MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9653090
• MDR Text Key: 199248628
• Report Number: 0001825034-2020-00429
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 0088030470352
• UDI-Public: (01)0088030470352
• Combination Product (y/n): N
• PMA/PMN Number: K150522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• 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: 110024464
• Device Lot Number: 947180
• Was Device Available for Evaluation?: No
• 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: ITEM: 010000665 G7 CUP LOT: 6122095.