MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID; PROTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530)

Event Date 08/24/2022

Event Type  Injury  

Event Description

It was reported that approximately 16 years post implantation of a left total hip arthroplasty, the patient was revised for concern of metallosis development and pain.During the revision, it was reported that the femoral head was extremely hard to remove as it was cold welded to the trunnion.A substantial amount of scar tissue was also removed from the hip joint.There were no surgical complications.No additional information was available.

Manufacturer Narrative

(b)(4).D10: cat# 139254 lot# 708230 m2a-magnum 42-50mm tpr insrt-3 0/-3mmt1.Cat# 157446 lot# 823450 m2a-magnum mod hd sz 46mm.Cat# 103206 lot# 731470 taperloc por fmrl 12.5x145.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: 0001825034-2024-00857, 0001825034-2024-00859.

• Brand Name: M2A-MAGNUM PF CUP 52ODX46ID
• 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: 19010960
• MDR Text Key: 338998970
• Report Number: 0001825034-2024-00858
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• 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

• Date FDA Received: 04/01/2024
• 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: US157852
• Device Lot Number: 720260
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• 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): Hospitalization; Required Intervention
• Patient Sex: Female