MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MAGNUM TAPER ADAPTER 42-50MM MINUS 3MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Discolored (1170); Material Erosion (1214); Metal Shedding Debris (1804)

Patient Problems Headache (1880); Pain (1994); Toxicity (2333)

Event Date 04/06/2015

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.(b)(4).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." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-03817 / 03818).

Event Description

Patient's legal counsel reported patient underwent right hip revision approximately seven years post-implantation.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Operative note reported revision due to pain, elevated metal ion levels, abnormal mars mri, headaches, nerve pain, popping, and clicking.During the procedure, synovial reaction, pseudotumor, cloudy fluid collection with debris, discoloration of the head and trunnion consistent with fretting and/or corrosion, and well-fixed stem were noted.The modular head was removed and replaced with ceramic head and a hip bearing was implanted.

• Brand Name: M2A MAGNUM TAPER ADAPTER 42-50MM MINUS 3MM
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5983950
• MDR Text Key: 55838821
• Report Number: 0001825034-2016-03818
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 139254
• Device Lot Number: 744180
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2008
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR