MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO B-MTRC MP FP HO 17; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

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

Event Date 12/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00068 the customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that approximately six years post implantation, the patient experienced a pseudotumor due to trunnionosis, which was aspirated.A revision is pending but has not been scheduled to date.Attempts have been made and no further information has been provided.

• Brand Name: ECHO B-MTRC MP FP HO 17
• 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: 18479182
• MDR Text Key: 332468077
• Report Number: 0001825034-2024-00069
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304697997
• UDI-Public: (01)00880304697997(17)321011(10)219380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• 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: 193117
• Device Lot Number: 219380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 136 KG