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

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign: (b)(6).The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon tried to place the g7 freedom constrained liner into the g7 cup however the liner wouldn't lock in correctly.Eventually, the surgeon was forced to use g7 high wall liner instead.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the devices were returned together.They were separated with the insert having scratches and scuffing.The liner has indentations on the lip of the device.The height and width of the device were measured and found in conformance to the print.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.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: G7 FREEDOM CONST E1 LNR 36MM G
• Type of Device: PROSTHESIS, 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: 17283354
• MDR Text Key: 318871558
• Report Number: 0001825034-2023-01514
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304989092
• UDI-Public: (01)00880304989092(17)260603(10)7042217
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000985
• Device Lot Number: 7042217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• 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
• Patient Age: 61 YR
• Patient Weight: 80 KG