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

Model Number N/A

Device Problems Positioning Failure (1158); Difficult to Insert (1316)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000662 g7 pps ltd acet shell 50d 6496615.110003621 g7 acetabular liner ceramic 32mm 6294411.Foreign report 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 - 2020 - 02749.

Event Description

It was reported patient underwent an initial hip replacement.During the procedure, the g7 high wall e1 liner was inserted.After several attempts to insert the liner, it remained loose, the surgeon elected to insert a g7 acetabular liner ceramic.It was inserted flat, yet it remained crooked in the shell.This liner became stuck in the shell and could not be removed.Removal attempts resulted in a fracture of the acetabulum and removal of the shell.A larger shell was implanted.Surgery was delayed by an hour.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.One g7 hi-wall e1 liner 36mm d and one biolox delta cer lnr 32mm d were returned and evaluated.Upon visual inspection the liner is level inside of the shell.There is visible damage to the liner that can be seen when looking through the plug locations.The device could not be disassembled and no further analysis could be completed.Visible damage is noted to the rim and outside diameter of the shell typical of a device that has been tried to implant and removed.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10270889
• MDR Text Key: 198874688
• Report Number: 0001825034-2020-02748
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527096
• UDI-Public: 00880304527096
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000934
• Device Lot Number: 6560469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 60