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

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Part: 650-0838, lot: 2019091311, delta cer fm hd 036/+4mm 12/14.Part: 010000663, lot: 6691977, g7 pps ltd acet shell 52e.Report source: (b)(6).

Event Description

It was reported that the patient was revised one year post-implantation due to liner wear.Attempts to obtain additional information have been made; however, no more is available at this time.Attempts have been made and no further information has been provided.

Manufacturer Narrative

The following sections were updated/corrected: a2, a3, a4, a5, b3, b4, b5, b7, d4, d10, e1, g3, g6, h1, h2, h6, h10.Correction: d6.

Event Description

It was reported that the patient was revised one year post-implantation due to pain.During the revision, it was noted that the poly liner was loosened and worn with diffuse metallosis in the surrounding soft tissues.The head and liner were replaced without complication.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues as reported as metallosis, poly wear, poly loosening, pain, no other complications reported.Mmi review: support reported event of wear, and loosening of the poly liner with good alignment both pre and post reported events.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of medical records.The articulating surface of the liner and non-articulating surface in the pole region appear to be in good condition (figure 2), however the non-articulating surface near the rim shows wear of the liner as shown by red arrows (figure 2 and figure 3) and damage at multiple regions in the form of scratches/gouges, as shown by the microscopy images in figure 3.Three images of a total of five radiographs were provided with (b)(4): one postprimary anteroposterior (ap) radiograph, two pre-revision radiographs (one ap and one lateral), and two post-revision radiographs (one ap and one lateral).The post-primary radiograph (3 days after surgery), the two pre-revision radiographs (23 days before revision) and the two postrevision radiographs were taken (1 month after revision).In the provided post-primary ap radiograph (figure 4), the ceramic head does not appear to be concentric with the acetabular shell, suggesting malpositioning/disassociation of the liner and ceramic head.However, this radiograph does not show the patient¿s full pelvis and therefore does not have the necessary bony landmarks to determine the inclination angle and anteversion of the acetabular component.The pre-revision ap and lateral radiographs (figure 5) show lateral subluxation of the ceramic head, which corroborates with the reported disassociation and wear of the liner.This radiograph also does not show the patient¿s full pelvis and therefore the inclination angle of the acetabular component could not be determined.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.The additional information does not change the root cause of the investigation.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 E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12154749
• MDR Text Key: 261206719
• Report Number: 0001825034-2021-02066
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000935
• Device Lot Number: 6747569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White