MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 56MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Adhesion(s) (1695); Metal Related Pathology (4530)

Event Date 11/17/2020

Event Type  Injury  

Event Description

It was reported that the patient was revised due to elevated metal ions and adverse local tissue reaction approximately 9 years post implantation.During the revision there was no significant metal debris or staining, minimal tissue necrosis, and weakened posterior capsule.The head and taper adapter were exchanged without complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant products: catalog number:139266 lot number:961790 brand name: m2a magnum tpr insrt; catalog number:157456 lot number: 814560 brand name: m2a magnum head; catalog number:us157862 lot number:315260 brand name: m2a-magnum pf cup; catalog number:192411 lot number:219480 brand name: echo por fmrl red nc.Multiple reports were submitted along with this report 0001825034-2022-00598.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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.H6 - component code - the appropriate code was not available to select.It should reflect mechanical.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following.Metal-on-metal right total hip arthroplasty with evidence of adverse local tissue reaction.Elevate metal ions, posterior capsule was completely weakened and repaired.Implants well fixed, no significant metal debris or staining.Reported event was confirmed by review of medical records provided.Review of the device history record(s) 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: M2A-MAGNUM MOD HD SZ 56MM
• 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: 13860633
• MDR Text Key: 287685833
• Report Number: 0001825034-2022-00599
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00880304428072
• UDI-Public: (01)00880304428072(17)310720(10)814560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 157456
• Device Lot Number: 814560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male