MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 54ODX48ID; PROSTHETIC, HIP

Model Number N/A

Device Problem Material Erosion (1214)

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

Event Date 02/24/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure 14 years post implantation due to pain and elevated metal ion levels.During the procedure noted hip abductor muscle with metal debris and tunneling to anterior capsule.The head and taper were exchanged without complication.The cup and stem remained implanted.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).157448 item name m2a-magnum mod hd sz 48mm lot # 474660 139252 item name m2a-magnum 42-50mm tpr insrt-6 lot # 653650 11-104113 item name mlry-hd por fmrl 13x170mm lot # 731310 multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2024 - 00201.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Device location is unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: persistent pain, elevated metal ions, mri negative for pseudotumor, negative esr/crp noted 30% deficiency in hip abductor muscle with evidence of metal disease within the deep tissue structures, tunneling anterior to femur through anterior capsule.No damage to trunnion, femur and acetabular well fix and stable remained implanted.Leg lengths equal and no complications.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

There is no update to the prior event description provided.

• Brand Name: M2A-MAGNUM PF CUP 54ODX48ID
• Type of Device: PROSTHETIC, 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: 18639401
• MDR Text Key: 334510207
• Report Number: 0001825034-2024-00202
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: US157854
• Device Lot Number: 334390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male