MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL RED NC 12X140MM; PROTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Scar Tissue (2060); Synovitis (2094); Metal Related Pathology (4530); Unequal Limb Length (4534)

Event Date 09/25/2023

Event Type  Injury  

Event Description

It was reported that approximately 9 years post implantation of a right total hip arthroplasty, the patient was revised for concern of metallosis development, elevated metal ion levels, and pain.The patient was noted to have a 7mm discrepancy between limbs.During the revision of the femoral head and limb lengthening procedure, scar tissue and synovial inflammation were also noted.There were no reported complications.No additional information was available.

Manufacturer Narrative

(b)(4).D10: cat# us157856, lot# 086360, m2a-magnum pf cup 56odx50id.Cat# 157450, lot# 709400, m2a-magnum mod hd sz 50mm.Cat# 139259, lot# 105620, m2a magnum 42-50m tpr insrt +6.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00860, 0001825034-2024-00861, and 0001825034-2024-00863.

• Brand Name: ECHO POR FMRL RED NC 12X140MM
• Type of Device: PROTHESIS, 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: 19011030
• MDR Text Key: 339000428
• Report Number: 0001825034-2024-00862
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070274
• 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: 04/01/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 192412
• Device Lot Number: 536270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: Female