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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/11/2018

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.Concomitant medical products: item number: 010000666, item name: g7 acetabular shell, lot #: 6295711.Item number: 010000985, item name: g7 freedom constrained liner, lot #: 6272326.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08216, 0001825034-2018-08218.

Event Description

It was reported during an initial hip arthroplasty two liners would not seat into the shell.The shell was removed after two liners were attempted to be implanted.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Udi# (b)(4).Complaint sample was evaluated and the reported event was confirmed.Upon receipt, the liner was assembled with the shell.The rim of the liner is gouged.The inner radius of the liner exhibits a few scratches.Scuffing was observed on the outer radius of the liner after it was removed from the shell as described above.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08216 - 1 , 0001825034 - 2018 ¿ 08218 - 1.

Event Description

No additional patient consequences were reported.

• Brand Name: G7 DUAL MOBILITY LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7792816
• MDR Text Key: 117443133
• Report Number: 0001825034-2018-08217
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK150522
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• 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: 110024465
• Device Lot Number: 706010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 66 YR