MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN G7 LINER; PROSTHETIC, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 12/15/2022

Event Type  Injury  

Event Description

It was reported that a right hip revision was performed due to liner wear and pain during high activity movement.The procedure was completed using another g7 liner and ceramic head.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00020.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.

Event Description

There is no update to the original complaint description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the liner is heavily damaged from removal.Based on image liner wear cannot not be decerned from the removal damage and debris present.The femoral head have what appear to be wear lines, scuffing and bio-debris present.No additional detail can be seen based on provided images.Part and lot identification are necessary for review of device history records, neither were provided.Radiographs were provided and reviewed by a health care professional.The image was reviewed and determined as it is a single undated image that would not enhance the investigation.A definitive root cause cannot 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.

• Brand Name: UNKNOWN G7 LINER
• Type of Device: PROSTHETIC, HIP
• 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: 16104625
• MDR Text Key: 306730264
• Report Number: 0001825034-2023-00019
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNK G7 LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK HEAD
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 154 KG