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

Model Number N/A

Device Problems Material Erosion (1214); Patient Device Interaction Problem (4001)

Patient Problems Ossification (1428); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: cat#us157848 m2a-magnum pf cup 48odx42id; cat#11-103206 taperloc por lat fmrl 12.5x145; cat#139252 m2a-magnum 42-50mm tpr insrt-6.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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 - 2022 - 00786 , 0001825034 - 2022 - 00788, 0001825034 - 2022 - 00789.

Event Description

It was reported the patient underwent a right hip revision approximately 14 years post implantation due to pain and elevated metal ions.During the revision metal on metal at the ball/socket as well as trunnionosis, small pseudotumor, aseptic loosening of the trunnion and acetabular component with no bone growth on posterior surface, and breach to bone in the acetabulum.The head and cup were exchanged without complications.The stem remained implanted.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6:component code: mechanical (g04) - head.Reported event was confirmed due to the review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: had a late dislocation of mom tha a few years ago with closed reduction, no surgery required.Right hip metal on metal failure, metal on metal at the ball/socket as well as trunnionosis, small pseudotumor, aseptic loosening of the acetabular component.Pain and elevated metal ions, small wall breach to bone in the acetabulum.Trunnion found to be unstable, stem found stable, acetabulum unstable with no bone on the posterior surface.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

• Brand Name: M2A-MAGNUM MOD HD SZ 42MM
• 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: 13976709
• MDR Text Key: 288377544
• Report Number: 0001825034-2022-00787
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 157442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female