MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 42MM PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Patient Device Interaction Problem (4001)

Patient Problems Ossification (1428); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant products: cat#us157848 m2a-magnum pf cup 48odx42id; cat#11-103206 taperloc por lat fmrl 12. 5x145; cat#139252 m2a-magnum 42-50mm tpr insrt-6. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00786 , 0001825034 - 2022 - 00788, 0001825034 - 2022 - 00789.

Event Description

It was reported the patient underwent a right hip revision approximately 14 years post implantation due to pain and elevated metal ions. During the revision metal on metal at the ball/socket as well as trunnionosis, small pseudotumor, aseptic loosening of the trunnion and acetabular component with no bone growth on posterior surface, and breach to bone in the acetabulum. The head and cup were exchanged without complications. The stem remained implanted. No additional information.

• Brand Name: M2A-MAGNUM MOD HD SZ 42MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13976709
• MDR Text Key: 288377544
• Report Number: 0001825034-2022-00787
• 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

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 157442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• 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 Treatment Data

Date Received: 04/01/2022 Patient Sequence Number: 1