MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 52ODX46ID; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Reaction (2414)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet taper insert cat#139254 lot#844730, biomet head cat#157446 lot#843560, biomet cup cat#us157852 lot#151290, biomet stem cat#11-103204 lot#939100.Reported event was confirmed with medical records provided.Review of the revision operative notes confirms that the patient had right revision due to pain and elevated metal ions.Operative notes states moderate serous fluid, no purulent fluid.No corrosion.No wear or loose bodies in socket.Scar tissue excised.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.This device remains implanted in the patient.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04741.

Event Description

It was reported that the patient has underwent an initial right hip arthroplasty.Subsequently, the patient was revised approximately 10 years later due to metallosis.It was noted the blood serum cobalt and chromium levels were elevated.During revision non purulent serous fluid and discolored tissue was noted in the hip space.No further event information available at the time of this report.

• Brand Name: M2A-MAGNUM PF CUP 52ODX46ID
• 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: 9611295
• MDR Text Key: 175855770
• Report Number: 0001825034-2020-00322
• Device Sequence Number: 1
• Product Code: KWY
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: N/A
• Device Catalogue Number: US157852
• Device Lot Number: 151290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2009
• 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