MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP

Model Number N/A

Device Problems Degraded (1153); Material Erosion (1214)

Patient Problems Failure of Implant (1924); Pain (1994); Local Reaction (2035); Metal Related Pathology (4530)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: us157852 m2a-magnum pf cup 739950, 13-103206 taperloc stem 882420, 139254 m2a-magnum tpr insrt 419680. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. 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: 0001825034-2022-00995.

Event Description

It was reported a patient underwent a right total hip arthroplasty performed. The patient was revised just over ten years post implant due to pain and elevated cobalt and chromium levels. It was discovered during the revision, pseudocapsules was noted, there was no obvious damage to tissues or surrounding structures; however, black discoloration associated with wear was noted. The femoral head was replaced with a dual mobility construct without complication. Attempts have been made and no further information has been provided.

• Brand Name: M2A-MAGNUM MOD HD SZ 46MM
• 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: 14239574
• MDR Text Key: 290311212
• Report Number: 0001825034-2022-00996
• 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
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 682120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• 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: 04/28/2022 Patient Sequence Number: 1