MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 010000664 g7 pps ltd acet shell 54f lot# 6281274.Item# 010000936 g7 hi-wall e1 liner 36mm f lot# 6256797.Foreign source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2019-01241, 0001825034-2019-01239.

Event Description

It was reported that during a total hip arthroplasty, the liner would not lock into the shell after multiple attempts.The cup was removed and a new cup was implanted.A new liner was attempted to be seated and this liner still would not seat after multiple attempts.A ceramic liner was then used in the new shell to complete the procedure.There was a delay in surgery of 90 minutes and there was a reported increase in surgical wound trauma due to the malfunction.No additional patient consequences were reported.Attempts to obtain additional information was made; however, none was available.

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.Reported event was confirmed as the device was returned and evaluated.Upon visual inspection, visible damage of the liners were noted.The shell showed no visible damage.Device history record (dhr) was reviewed and no discrepancies 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 HI-WALL E1 LINER 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8459652
• MDR Text Key: 140156992
• Report Number: 0001825034-2019-01240
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000937
• Device Lot Number: 6126165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 65