MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 7 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Swelling (2091); Joint Dislocation (2374)

Event Date 10/30/2015

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 13 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.¿ number 20 states, "persistent pain." this report is based on allegations set forth in patient¿s complaint, and the allegations contained therein are unverified.This report is number 1 of 2 mdr's filed for the same event (reference 1825034-2015-04726 and 04727).

Event Description

It was reported that patient underwent right partial knee arthroplasty on (b)(6) 2015.During the procedure, tibial bearing was implanted then removed due to tracking complications.Subsequently, patient alleges that patient experienced swelling, pain when walking, and felt movement within her knee.On (b)(6) 2015, patient was revised due to dislocation.During this procedure, the tibial bearing was removed and replaced.It was further noted that dislocation of the bearing tore the acl.Another procedure to repair the acl has been indicated; however, no such procedure has been reported at this time.This report is based on allegations set forth in patient's complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that patient underwent right partial knee arthroplasty on (b)(6) 2015.Subsequently, patient alleges that patient experienced swelling, pain when walking, and felt movement within her knee.On (b)(6) 2015, patient was revised due to dislocation.During this procedure, the tibial bearing was removed and replaced.It was further noted that dislocation of the bearing tore the acl.Another procedure to repair the acl has been indicated; however, no such procedure has been reported at this time.This report is based on allegations set forth in patient铠complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Maude report mw5060005 was received regarding the event.Not returned by patient.

Manufacturer Narrative

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

• Brand Name: OXF ANAT BRG RT SM SIZE 7 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend 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: 5235314
• MDR Text Key: 31575020
• Report Number: 0001825034-2015-04726
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP100014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 159572
• Device Lot Number: 2777720
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2012
• 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: 50 YR
• Patient Weight: 68