MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM M2A MOD HEAD +6MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Slipped (1584); Metal Shedding Debris (1804); Delamination (2904); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Test Result (2695)

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-00336 / 00337).

Event Description

It was reported that a patient underwent an initial left total hip arthroplasty in 1992.Subsequently, the patient was revised on (b)(6) 2004 due to implant failure.Operative report noted metal debris, staining of the tissue, loose cup, delamination of the acetabular shell, areas of wear on the liner, and burnishing on the head during the procedure.The patient is being considered for revision due to elevated cobalt levels.

• Brand Name: 32MM M2A MOD HEAD +6MM 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: 5407884
• MDR Text Key: 37421095
• Report Number: 0001825034-2016-00336
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 11-163671
• Device Lot Number: 275590
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2004
• 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