MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MAGNUM SYSTEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Difficult to Remove (1528)

Patient Problem Reaction (2414)

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unknown if product is being returned to zimmer biomet for investigation, as its location is unknown; however, an investigation has been initiated.Once the investigation has been completed, a follow- up mdr will be submitted.

Event Description

Medical records received indicate difficulty removing the femoral head, which resulted in a delay of one hour.Operative report indicates the head was removed with a burr and black corrosion on the taper adapter and trunionosis were present within the joint.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.A definitive root cause could not be determined with information available.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and evaluation of complaint sample.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.M2a magnum tpr adpr ti dia42-5 0/0mmt1 item# 139256 lot# 747300 was returned and evaluated.Upon visual inspection the device had damage to the taper location and the outer shell.There was some visible discoloration to the inside taper.Sem analysis determined damage over the majority of the surface with severe corrosion attack and abundant corrosion debris.The additional information does not change the outcome of the previous investigation.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.

Event Description

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

• Brand Name: M2A MAGNUM SYSTEM
• Type of Device: PROSTHESIS, HIP
• 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: 6487477
• MDR Text Key: 72653749
• Report Number: 0001825034-2017-02493
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 139256
• Device Lot Number: 747300
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2006
• 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): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male