MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOMXL 36MM RLC LNR MROM SZ24; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 10/16/2015

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.The following sections could not be completed with the limited information provided.(b)(6).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity.Muscle and fibrous tissue laxity can also contribute to these conditions." this report is based on allegations set forth in patient's complaint, and the allegations contained therein are unverified.This report is number 3 of 4 mdrs filed for the same event (reference 1825034-2015-05174 / 05177).

Event Description

Patient reported they underwent an initial hip arthroplasty on (b)(6) 2011.Subsequently, the patient was revised on (b)(6) 2015 due to loosening.Patient reported the cup was well-fixed.The head, liner, and locking ring were removed and replaced.The patient dislocated six times and underwent manipulation procedures on unknown dates.The patient was further revised on (b)(6) 2015 due to unknown reasons.The head, liner, and locking ring were removed and replaced.Subsequently, the patient was revised on (b)(6) 2015 due to unknown reasons.All components were removed and replaced.This report is based on allegations set forth in patient's complaint, and the allegations contained therein are unverified.

• Brand Name: ARCOMXL 36MM RLC LNR MROM SZ24
• 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: 5331781
• MDR Text Key: 34567080
• Report Number: 0001825034-2015-05176
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051411
• 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: 12/11/2015

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: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: XL-105994
• Device Lot Number: 976950
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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: 76 YR