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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Reaction (2414)

Event Date 05/19/2015

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Concomitant medical products- biomet m2a universal shell, catalog#: 15-103682, lot#: 646000. Biomet taperlock, catalog#: 11-103206, lot#: 996730. Multiple mdr reports were filed for this event. 0001825034-2017-02262, 0001825034-2017-02263.

Event Description

It was reported patient underwent a right hip revision procedure approximately seven years post-implantation due to metal sensitivity. The femoral head was revised.

• 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: 6464355
• MDR Text Key: 109783836
• Report Number: 0001825034-2017-02263
• 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,Followup,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-163688
• Device Lot Number: 531550
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2008
• 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 Treatment Data

Date Received: 04/06/2017 Patient Sequence Number: 1