MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 50MM; 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  

Manufacturer Narrative

(b)(4).D10: cat# us157856 lot# 086360 m2a-magnum pf cup 56odx50id, cat# 139259 lot# 105620 m2a magnum 42-50m tpr insrt +6, cat# 192412 lot# 536270 echo por fmrl red nc 12x140mm.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, 0001825034-2024-00862, 0001825034-2024-00863.

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.

• Brand Name: M2A-MAGNUM MOD HD SZ 50MM
• 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: 19010995
• MDR Text Key: 338999609
• Report Number: 0001825034-2024-00861
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• 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: 157450
• Device Lot Number: 709400
• 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
• 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): Life Threatening; Required Intervention
• Patient Sex: Female