MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER MINUS 3MM NECK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Mechanical Problem (1384)

Patient Problem Foreign Body Reaction (1868)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-04968 / 04969).

Event Description

It was reported patient underwent right hip revision approximately seven years post-implantation due to patient allegations of adverse reaction to metal debris and mechanical complication of internal joint prosthesis.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned mod head showed foreign material in the tapered hole as well as nicks and scratches on the od (exterior spherical surface) of the head.Eds analysis of the polished bearing surface of the modular head gave a chemical composition consistent with cocr mo alloy.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER MINUS 3MM NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6139826
• MDR Text Key: 61289243
• Report Number: 0001825034-2016-04969
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 11-173661
• Device Lot Number: 062630
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Date Manufacturer Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 68