MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 42MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Noise, Audible (3273); Difficult or Delayed Separation (4044)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 11/13/2019

Event Type  Injury  

Event Description

It was reported patient underwent a right hip revision approximately 12 years post implantation due to pain, noise, elevated metal ions, loosening, migration, and altr.During the revision noted greenish fluid, inflamed synovial tissue and loose acetabular component.The cup, head, and taper adapter were exchanged with the taper adapter and head difficult to remove.The stem remained implanted.No additional information on the reported event.

Manufacturer Narrative

(b)(4).Concomitant medical products: us157848-m2a-magnum pf cup 48odx42id- 092580; 139254- m2a-magnum 42-50mm tpr insrt-3- 356390; x12-171309-integral/x por red prox 9mm- 308820.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02539.0001825034 - 2022 - 02581.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 component code: mechanical (g04) - head.Complaint was confirmed via medical records that were provided and reviewed by a health care professional.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.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 42MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15789364
• MDR Text Key: 303568509
• Report Number: 0001825034-2022-02580
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

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: 11/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 157442
• Device Lot Number: 762750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female