MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM M2A HI CARBON HD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Initial reporter - the article was written by wataru ando, kengo yamamoto, takashi atsumi, satoshi tamaoki, kazuhiro oinuma, hideaki shiratsuchi, hirohiko tokunaga, yutaka inaba, naomi kobayashi, masaharu aihara and kenji ohzono.This report is number 2 of 2 mdr's filed for the same patient (reference 1825034-2016-02983 / 02984).Device remains implanted.

Event Description

Information was received based on review of a journal article titled, "comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study", which aimed to investigate potential advantages of magnum group compared to conventional group terms of range of motion, dislocation while maintaining the same function improvement and pain reduction and to investigate metal ion release in asia population.A patient identified in the article experienced elevated metal ion levels approximately twenty-four months post-implantation.Further patient outcome is unknown.

Manufacturer Narrative

This follow-up report is being filed to relay this report is a duplicate of 1825034-2016-00010 and 1825034-2016-00184.

• Brand Name: 32MM M2A HI CARBON HD STD NK
• 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: 5851674
• MDR Text Key: 51339836
• Report Number: 0001825034-2016-02984
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 11-163688
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 69 YR
• Patient Weight: 61