MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 36MM D; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Date 04/28/2021

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 has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01138, 0001825034-2022-01142.

Event Description

It was reported that approximately fourteen (14) days post implantation of the right hip, the patient developed a pulmonary embolism, requiring a one day hospitalization.Pulmonary embolism resolved without further complication.Upon follow-up, the patient reported no problems and was very satisfied.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 patient developed a pulmonary emboli two weeks post total hip arthroplasty.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.If a dvt/ blood clot breaks free, it may travel through the bloodstream and block blood flow to the lungs.This complication is called a pulmonary embolism.Total joint patients are typically placed on medication post-operative for a period of time to help prevent the development of dvt/blood clot formation that can lead to an pe.As the complaint indicated the patient developed a post-operative complication, it can be implied medical intervention was completed to treat the pe.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 ARCOMXL LNR 36MM D
• 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: 14290921
• MDR Text Key: 291484490
• Report Number: 0001825034-2022-01139
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526075
• UDI-Public: (01)00880304526075(17)260228(10)63290540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• 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: 010000817
• Device Lot Number: 63290540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2016
• 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: CAT#: 110010243 G7 SHELL LOT#: 648668450; CAT#: 51-103090 TAPERLOC LOT#: 6851144; CAT#: 650-0661 DELTA HEAD LOT#: 3035182
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: Black Or African American