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

Model Number N/A

Device Problems Difficult to Remove (1528); Metal Shedding Debris (1804)

Patient Problems Bone Fracture(s) (1870); Rash (2033); Vertigo (2134); Test Result (2695)

Event Date 05/04/2015

Event Type  Injury  

Event Description

It was reported patient underwent a right total hip arthroplasty on (b)(6) 2001 and a left total hip arthroplasty on (b)(6) 2002.Subsequently, patient underwent a left hip revision procedure on (b)(6) 2015 allegedly due to elevated metal ion levels, rashes and vertigo.It was further reported that the acetabular cup removal tool was unable to release the cup and the cup was removed with the screws still intact.It was reported that the patient's pelvic bone was allegedly fractured during the removal of the acetabular cup.The modular head, metal liner and acetabular cup were removed and replaced and a competitor cup removal tool was utilized to complete the procedure.A 60 minute delay was reported.There has been no reported right hip revision procedure to date.

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.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 2 of 5 mdrs filed for the same event (reference 1825034-2015-02021 / 02025).

• Brand Name: 32MM M2A MODULAR 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: 4769924
• MDR Text Key: 5791990
• Report Number: 0001825034-2015-02022
• 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: Patient
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 11-163667
• Device Lot Number: 030810
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2001
• 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: 54 YR