MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-MAGNUM MODULAR HEAD; HIP PROSTHESIS

Model Number N/A

Device Problems Corroded (1131); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: pn #12-103206, taperloc femoral stem, ln #522830.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports:0001825034-2017-01812; 0001825034-2017-01809;0001825034-2017-01805.

Event Description

It is reported by legal counsel for patient reported that patient underwent a left hip revision procedure approximately 5 years post- implantation due to elevated ion levels.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Operative record reported revision due to elevated metal ion levels, squeaking of the implant, osteolysis.Significant foreign body reaction tissue was debrided during the revision.The femoral head, taper and acetabular cup were removed and replaced; a poly liner was implanted.

Manufacturer Narrative

This follow up report is being filed to relay corrected and additional information.(b)(4).No devices or photos of the devices were received; therefore, the condition of the components is unknown.Additionally, visual and dimensional evaluations could not be performed.This complaint was determined not to be a new confirmed quality or manufacturing issue.Review of device history records found these units were released to distributor with no deviations or abnormalities.Root cause could not be determined with information available.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: M2A-MAGNUM MODULAR HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6421983
• MDR Text Key: 70515654
• Report Number: 0001825034-2017-01809
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK833175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 467670
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2008
• 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: 51 YR
• Patient Weight: 91