MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MODLUAR HEAD COMPONENT; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Detachment of Device or Device Component (2907)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 03/25/2022

Event Type  Injury  

Event Description

It was reported that approximately eighteen years post-implantation, the patient was revised due to disassociation of the head and stem, trunnion fracture, and significant metal related pathology.All components were revised with extension cabling and claw plating system used to secure femur and reduce eto/bone fragments and proximal femur fracture.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: M2A MODLUAR HEAD COMPONENT
• 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: 19114792
• MDR Text Key: 340239565
• Report Number: 0001825034-2024-01028
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-173664
• Device Lot Number: 368870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male