MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50 TPR INSRT STD; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Necrosis (1971); Pain (1994)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 157450-m2a-magnum mod hd sz 50mm- 226540; us157856-m2a-magnum pf cup 56odx50id- 125120; x180312-bi-metric/x por nc 12x140- 637830.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00052, 0001825034 - 2021 - 00053, 0001825034 - 2021 - 00054.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.Product location unknown.

Event Description

It was reported the patient underwent a left hip revision approximately 13 years¿ post implantation due to pain, elevated metal ions, pseudotumor, and muscle necrosis.During the revision, metallosis and taper corrosion were noted.Necrotic tissue removed from around the acetabulum.The femoral head was replaced with a dual mobility system.The shell and stem were left intact.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed via medical records/radiographs 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.A review of the device history records 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.

Event Description

No further event information available at the time of this report.

• Brand Name: M2A-MAGNUM 42-50 TPR INSRT STD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11153870
• MDR Text Key: 246836811
• Report Number: 0001825034-2021-00055
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

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: 03/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 139256
• Device Lot Number: 396420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention