MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50M TPR INSRT +3; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Cyst(s) (1800); Pain (1994); Local Reaction (2035); Synovitis (2094); Osteolysis (2377)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 139258 m2a-magnum 42-50m tpr insrt +3 146420, 157448 m2a-magnum mod hd sz 48mm 872140, us157854 m2a-magnum pf cup 54odx48id 205570, x180311 bi-metric/x por nc 11x135 031770.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.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: 0001825034-2017-02115, 0001825034-2017-02116, 0001825034 -2021 -00795.

Event Description

It was reported that the patient had an initial right total hip arthroplasty performed.The patient was revised approximately eight years later due to pain.During the revision, acetabular osteolysis, metallosis, and reactive synovitis was noted.It was also noted that there was minimal bony on growth around the acetabular shell.Corrosion was discovered during investigation of the returned head.No additional information is available.

• Brand Name: M2A-MAGNUM 42-50M TPR INSRT +3
• 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: 11561001
• MDR Text Key: 245874379
• Report Number: 0001825034-2021-00848
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2021

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: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 139258
• Device Lot Number: 146420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2008
• 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