MAUDE Adverse Event Report: BIOMET ORTHOPEDICS FREEDOM RINGLOC CONSTRAINED LINER 36MM / PLUS 5MM STANDARD FACE SIZE 23; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 08/24/2016

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 4 states " loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." number 11 states "11.Wear and/or deformation of articulating surfaces." number 14 states "postoperative bone fracture and pain." this report is number 3 of 5 mdr's filed for the same patient (reference 1825034-2016-03753 / 03754 / 03755 / 03756 / 03772).

Event Description

It was reported that patient underwent a right total hip revision approximately 8 years post-implantation due to pain, locking ring fracture, liner disassociation, and dislocation.During the revision, a deformed liner and wear of the locking ring slot on the cup were noted.

• Brand Name: FREEDOM RINGLOC CONSTRAINED LINER 36MM / PLUS 5MM STANDARD FACE SIZE 23
• 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: 5971735
• MDR Text Key: 55419029
• Report Number: 0001825034-2016-03755
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030047
• 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: 08/23/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 11-107022
• Device Lot Number: 192100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2008
• 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: 63 YR