MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM E; PROTHESIS, HIPS

Model Number N/A

Device Problems Degraded (1153); Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign: china.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during surgery, the liner size on the label is e, and the product is etched with b.The doctor doubted inconsistent size information.The surgeon implanted the liner, and the liner was loose after being implanted.The surgeon removed the liner and found the etched issue.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the provided pictures identified shows the liner has a "b" etched on the device.No other issues can be seen.Review of the device history record(s) was not performed as this complaint meets the definition of a limited investigation as the device functions as intended.A complaint history review is not required as part of a limited investigation.Medical records were not provided.No device problem was found as all g7 poly liners are etched with a "b" for biomet.Unable to confirm complaint as there was no problem found with the device.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 additional event information to report at this time.

• Brand Name: G7 HI-WALL E1 LINER 36MM E
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18519821
• MDR Text Key: 333001252
• Report Number: 0001825034-2024-00110
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527102
• UDI-Public: (01)00880304527102(17)230315(10)7477989
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 010000935
• Device Lot Number: 7477989
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1