MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK M2A MAGNUM MODULAR HEAD; PROSTHETIC, HIP

Model Number N/A

Device Problems Material Erosion (1214); Separation Failure (2547)

Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2024 - 00896; 0001825034 - 2024 - 00897.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.

Event Description

It was reported that the patient underwent a revision procedure 14 years and 10 months post implantation due to pain and elevated metal ion levels.Altr, osteolysis, and cold welding were also confirmed during the procedure.The head and cup were exchanged without any known complications.There is no additional information available at the time of this report.

• Brand Name: UNK M2A MAGNUM MODULAR HEAD
• 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: 19018569
• MDR Text Key: 339095002
• Report Number: 0001825034-2024-00898
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN BI-METRIC STEM, UNKNOWN M2A MAGNUM CUP.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male