MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 48ODX42ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Pain (1994); Metal Related Pathology (4530)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat# 157442 lot# 831010 m2a-magnum mod hd, cat# 139254 lot# 000880 m2a-magnum 42-50mm, cat# 11-104111 lot# 814590 mlry-hd por fmrl.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified the devices remain assembled upon receipt.Visual inspection found scratching on the exposed surface of the insert.The taper is etched -3.Dark debris and scuffing are present inside the taper of the insert.Scratching was observed on the outside of the head in multiple locations.The head is etched 42.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-10510, 0001825034-2018-10508, 0001825034-2018-11559.

Event Description

It was reported the patient underwent a revision approximately 10 years post initial surgery for ongoing pain, discomfort, mild metalosis, elevated ions, and mild trunnionosis with collected fluid around the hip.No additional information.

• Brand Name: M2A-MAGNUM PF CUP 48ODX42ID
• 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: 14305653
• MDR Text Key: 291485846
• Report Number: 0001825034-2022-01153
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062995
• 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
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: N/A
• Device Catalogue Number: US157848
• Device Lot Number: 724930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2007
• 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 Age: 71 YR
• Patient Sex: Male