MAUDE Adverse Event Report: BIOMET ORTHOPEDICS IMPACT ARCOM RIMLOC LNR 2X28; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)

Patient Problems Cyst(s) (1800); Complaint, Ill-Defined (2331)

Event Date 07/18/2013

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, ¿fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.¿ this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-04062 / 04063).

Event Description

It was reported that patient underwent a left total hip arthroplasty in 1993.Subsequently, a revision procedure was performed on (b)(6) 2006 due to unknown reasons.It was further reported the patient underwent another revision procedure on (b)(6) 2013 due to wear of the modular head and acetabular cup, black staining and fracture of the acetabular liner.Information received in operative report notes metallosis, abductor failure, acetabular lysis, segmental bone loss, and cysts.The acetabular cup, liner and modular head were replaced with a legacy biomet modular head and legacy zimmer cup and liner.

• Brand Name: IMPACT ARCOM RIMLOC LNR 2X28
• 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: 5097257
• MDR Text Key: 26539750
• Report Number: 0001825034-2015-04062
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/24/2015

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: 07/31/2009
• Device Model Number: N/A
• Device Catalogue Number: 12-112022
• Device Lot Number: 571340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2004
• 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
• Patient Age: 70 YR