MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 28MM A; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that patient underwent right total hip arthroplasty over 10 years ago with competitor devices.The patient was revised within the last few years due to major liner wear.A zimmer biomet g7 liner was used with competitor shell, screws, head, and stem during this revision.The g7 liner was cemented in off label with no issues.Subsequently, patient is being considered for a revision due to the liner disassociating from the shell.No revision has taken place to this date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b1, b2, h1; h2; h3; h6 reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.The following sections were {update/corrected} updated:a2, a3, b3, b5, d1, d2, d4, d6, d7, e1, g4, g5, h2, h3, h4.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient underwent revision right tha of competitor product.During revision, a zimmer biomet liner was cemented into the existing competitor cup.Patient was revised again approximately 1.5 years later due to the cemented liner dissociating from the shell and the head articulating with the shell.A zimmer biomet triflange was constructed and used to complete the revision.No further event information available at the time of this report.

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.X rays were provided and reviewed by a health care professional.X ray results demonstrate the following: right total hip arthroplasty with evidence of polyethylene wear and possible deformity of the acetabular cup superiorly.Irregular sclerosis involving the superior acetabular region of uncertain etiology.A review of the device history records identified no deviations or anomalies during manufacturing.The root cause is directly attributed to off label use by cementing a g7 liner with a competitor cup.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: G7 HI-WALL E1 LINER 28MM A
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10019530
• MDR Text Key: 200024314
• Report Number: 0001825034-2020-01733
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000913
• Device Lot Number: 3841568
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR