MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FREEDOM CONST E1 LNR 36MM H; PROSTHETIC, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 07/18/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure 2 years and 20 days post implantation due to disassociation of the liner from the cup.The liner was exchanged.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).D10: 110010269, g7 osseoti multihole 62mm h, lot number is 6448885; 11-107019, freedom constr hd 36mm t1 +3mm, lot number is 322330.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2023 - 01866.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, a supplemental medwatch will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on evaluation of medical records.Review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported part and lot combination(s).Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: constrained liner disassociated from the g7 cup this dr isn¿t sure when.Partial dislocation of the femoral head and dislocated acetabular cup liner.Increased right acetabular inclination angle measures 56 degrees.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.

Event Description

There is no update to the prior event description provided.

• Brand Name: G7 FREEDOM CONST E1 LNR 36MM H
• 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: 17539483
• MDR Text Key: 321065502
• Report Number: 0001825034-2023-01865
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304989108
• UDI-Public: (01)00880304989108(17)250212(10)6745009
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• 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: 010000986
• Device Lot Number: 6745009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male