MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M2A SHELL; PROTHESIS, HIPS

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Metal Related Pathology (4530)

Event Date 01/09/2024

Event Type  Injury  

Event Description

It was reported the patient was implanted with zimmer biomet products on an unknown date.Subsequently, the patient was revised due to metal-on-metal complications.The head was explanted, and the patient was implanted with an active articulation head.

Manufacturer Narrative

(b)(4).D10: unknown m2a head unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00413.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: UNKNOWN M2A SHELL
• Type of Device: PROTHESIS, HIPS
• 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: 18698796
• MDR Text Key: 335295730
• Report Number: 0001825034-2024-00417
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• 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: UNK M2A SHELL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention