MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MODULAR HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); No Information (3190)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: cat# us157856 m2a-magnum pf cup 56odx50id lot# 649140; cat# 139256 m2a-magnum 42-50 tpr insrt std lot# 156900; cat# 13-103208 taperloc por red/lat 15x150 lot# 223840.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 - 2020 - 03577, 0001825034 - 2020 - 03579, 0001825034 - 2020 - 03580.

Event Description

It was reported the patient underwent a hip revision approximately 13 years post implantation due to magnetic resonance imaging (mri) revealed fluid around the hip and elevated metal ion levels.No additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported the patient underwent a left hip revision approximately 13 years post implantation due to pain and elevated cobalt levels.No significant findings were dictated in the revision notes.The stem was left in place, all other components were revised without complication.

Manufacturer Narrative

Reported event was confirmed by review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: trunnion noted to be stable without corrosion, stem with appropriate anteversion and was stable.Stem left in place, all other components replaced without complications / significant findings.Cultures obtained, no results provided.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.The following sections were updated/corrected complaint sample was evaluated and the reported event was confirmed.An m2a-magnum mod hd sz 50mm was returned and evaluated against the complaint.Visual inspection found scratches and scuffing on the outer radius such that the finish has become dull.Dings and scratches were also observed on the rim.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: M2A-MAGNUM MODULAR HEAD
• 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: 10568513
• MDR Text Key: 207982929
• Report Number: 0001825034-2020-03578
• 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,Followup,Followup,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 157450
• Device Lot Number: 983150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 12/22/2020; 03/03/2021; 03/25/2022
• Supplement Dates FDA Received: 10/30/2020; 01/05/2021; 03/05/2021; 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2007
• 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
• Patient Weight: 122 KG