MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN CONSTRAINED LINER; HIP PROSTHESIS

Model Number N/A

Device Problems Entrapment of Device (1212); Material Erosion (1214); Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Joint Dislocation (2374)

Event Date 03/17/2014

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

Patient reported a revision approximately 1 month post-implantation due allegation of failed locking mechanism.This report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.Additional information received in patient's medical records indicates the patient was revised approximately 1 month post-implantation due to dislocation.Revision operative report noted dislocation, wear and impingement of the constrained liner, abductor dysfunction and a hematoma.During the procedure, the patient's leg was lengthened to add stability and the head and liner were removed and replaced.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001822565-2017-06347.

• Brand Name: UNKNOWN CONSTRAINED LINER
• Type of Device: HIP PROSTHESIS
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6312653
• MDR Text Key: 66859843
• Report Number: 0001825034-2017-00508
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: 09/08/2017
• Supplement Dates FDA Received: 09/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR