MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 40MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: cat# 192110 echo por fmrl lat nc 10x130mm lot# 146930; cat# 139259 m2a magnum 42-50m tpr insrt +6 lot# 348150; cat#us157854 m2a-magnum pf cup 54odx48id lot#091380.The device will not be returned for analysis, as the device location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03595, 0001825034 - 2020 - 03596, 0001825034 - 2020 - 03606.

Event Description

It was reported the patient underwent a left hip revision approximately 10 years post implantation due to metallosis, pain that interfered with activities of daily living, and osteolysis.During the procedure, the surgeon noted the following: elevated cobalt and chromium levels, difficulty removing the head, and femoral stem and acetabular cup were well fixed.The stem and cup were retained.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; g4; h2; h3; h4; h6 d4 item number corrected.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain which interfered with activities of daily living.Elevated cobalt and chromium.Mri showed pseudotumor.X-ray shows lysis around femoral and acetabular components.Significant amount of friable grayish/brown tissue consistent with metallosis was encountered and sent for analysis.Removal of the femoral head was difficult and took repeated attempts.Femoral component was well fixed despite concern on x-ray for lysis.Attempt made to extract however stem remained well fixed and was left in place.Attempt also made to remove acetabular component, however remained well fixed.A definitive root cause cannot 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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.An m2a-magnum mod hd sz 40mm was returned and evaluated against the complaint.Visual inspection found tool marks on the rim and outer radius of the head.The head is also scuffed such that the finish of the outer radius is discolored and dull.Scratching is present on the outer radius.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.The additional information does not change the outcome of the previous investigation.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.

• Brand Name: M2A-MAGNUM MOD HD SZ 40MM
• 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: 10585653
• MDR Text Key: 208501371
• Report Number: 0001825034-2020-03597
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 157448
• Device Lot Number: 946000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male