MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOMXL 40MM +3 MROM LNR SZ 24; PROSTHESIS, HIP

Model Number N/A

Device Problem Failure to Disconnect (2541)

Patient Problems Unspecified Infection (1930); Tissue Damage (2104)

Event Date 06/19/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a right total hip arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to infection.All components were removed and replaced with competitor spacer molds.During the procedure, the taper would not disengage between the proximal and distal acros bodies.An osteotomy to remove the product was performed which caused a 45 minute delay in the procedure.

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: "early or late postoperative infection and/or allergic reaction." review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.This report is number 7 of 9 mdrs filed for the same event (reference 1825034-2015-03040 / 03048).

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

Manufacturer Narrative

Product was returned to manufacturer, however evaluation is not necessary due to device being reported for infection.This report is number 7 of 9 mdrs filed for the same event (reference 1825034-2015-03040 / 03048).Reported for infection.

• Brand Name: ARCOMXL 40MM +3 MROM LNR SZ 24
• 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: 4919136
• MDR Text Key: 6430343
• Report Number: 0001825034-2015-03046
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2015

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: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: XL-108424
• Device Lot Number: 791610
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2015
• Initial Date FDA Received: 07/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2013
• 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: 53 YR