MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A 32MM TAPER SYSTEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Reaction (2414)

Event Date 05/19/2015

Event Type  Injury  

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records (dhr) for the head and taper liner identified no deviations or anomalies.Metal on metal complaints will be monitored through monthly post market surveillance trending process.The reported components were reviewed for compatibility with no issues noted.Without the opportunity to examine the complaint product, root cause of the reported event cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filled accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

Patient underwent a right hip revision procedure approximately seven years post-implantation due to pain and elevated ion levels.The report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.

• Brand Name: M2A 32MM TAPER 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: 6816219
• MDR Text Key: 83468314
• Report Number: 0001825034-2017-02262
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 15-105044
• Device Lot Number: 719680
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2008
• 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
• Treatment: (B)(4); (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention