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

Catalog Number 157444

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Reaction (2414)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Part # unknown / unknown taper/ lot # unknown.Part #unknown / unknown cup/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: (b)(4).

Event Description

It was reported that patient underwent right hip revision surgery approximately 9 years post implantation due to severe pain, elevated metal ion levels and metallosis.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.D10 - medical products - pn: 51-100120, taperloc type1 pps stem, ln: 2109924.Pn: 139256, m2a magnum taper insert, ln: 653290.Pn: us157850, m2a magnum cup, ln: 022430.Reported event was unable to be confirmed.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

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 updated: d9; h2; h3; h6.Component code: mechanical (g04) - head.Visual examination of the returned product identified the finish of the head has become very dull.Scratches are present inside the finish.Foreign debris remains affixed to the porous coating of the cup.Some of the debris has transferred to the inner radius of the cup and the taper of the insert.Standard scratching and scuffing is present on the inner radius.The exposed face of the taper insert is scratched.The insert is etched std foreign debris from the cup has spread to the taper of the insert.The taper also exhibits scratching.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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): .; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11245927
• MDR Text Key: 229298811
• Report Number: 0001825034-2021-00286
• 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,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/13/2022

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: 02/28/2021
• Device Catalogue Number: 157444
• Device Lot Number: 638040
• 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: 01/08/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 01/28/2021; 03/17/2021; 07/12/2022
• Supplement Dates FDA Received: 02/12/2021; 03/19/2021; 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2011
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female