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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Metal Related Pathology (4530)

Event Date 05/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: item # 139256 item name m2a-magnum 42-50 tprinsrt std lot #929850.Item # 51-103090 item name tprlc 133 type1 pps so9x137mm lot # 2588521.The device will not be returned for analysis location unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02623.

Event Description

It was reported the primary left tha was performed.Subsequently developed elevated metal ions, and pseudotumor.Revision of left tha was performed nine(9) years post implantation.And surgeon noted metallosis of left hip.Head/neck exchange to dual active mobility system.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  review of the device history records identified no deviations or anomalies during manufacturing no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient was revised due to elevated metal ions and pseudotumor.Green staining, pseudotumor removed.Removal of 46mm ball with standard neck, no corrosion noted.Dual mobility bearing placed.A definitive root cause could not be determined if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: M2A-MAGNUM MOD HD SZ 46MM
• Type of Device: PROSTHETIC, 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: 12467413
• MDR Text Key: 271262150
• Report Number: 0001825034-2021-02624
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 990520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2010
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 64 KG