MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM F; PROSTHESIS HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

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

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical devices: 010000928, g7 hi-wall e1 liner 32mm f, 6099083 , unknown shell, unknown, unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03824.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 that during right hip revision surgery, the liner would not seat into the shell.The surgery was completed with another product.Surgeon assesment of bone quality was poor.No additional information was made available.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed visible deformation and indentation of the scallops and no damage to the out radius of the liner.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 HI-WALL E1 LINER 32MM F
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7590620
• MDR Text Key: 110713304
• Report Number: 0001825034-2018-03823
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/22/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000928
• Device Lot Number: 6176990
• Other Device ID Number: (01) 0 0880304 52704 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 110010246G7 OSSEOTI 4 HOLE SHELL 56MM F
• Patient Age: 49 YR