MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A TAPER LINER; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Metal Shedding Debris (1804)

Patient Problem Pain (1994)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant products: 11-163690, m2a head, 351920, 15-103688, m2a shell, 767400, 11-103205, taperloc hip system, 171390.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 00587, 0001825034-2017-00584.

Event Description

It was reported patient had a revision procedure eleven years post-implantation due to osteolysis, metallosis, elevated metal ion levels, and pain.Additional information received in revision operative report noted corrosion material was around the metal-on-metal articulation.Corrosion was also found around the head and around the liner consistent with wear.The patient also had significant bone loss and aseptic, lymphocyte-dominated vasculitis-associated lesion (alval).Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was confirmed by review of medial records and x-rays provided.X-ray revealed the patient had arthritis with postol grip deformity; there was a large medial wall and inferior osteophytes.Device history record was reviewed and no discrepancies relevant to the reported event were found.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 TAPER LINER
• 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: 6801598
• MDR Text Key: 82947269
• Report Number: 0001825034-2017-06465
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 15-105044
• Device Lot Number: 921890
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2005
• 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: 57 YR
• Patient Weight: 93