MAUDE Adverse Event Report: BIOMET UK LTD OXF ANAT BRG LT SM SIZE 3 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Muscle Weakness (1967)

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 is being reported to fda on one medwatch as the limited information available indicates that a revision procedure is (or may be) needed.Should additional information be received regarding a revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.Remains implanted.

Event Description

It was reported that patient underwent bilateral partial knee arthroplasties on unknown dates.Subsequently, patient experienced buckling with quadriceps weakness in both knees, and patient previously experienced a fall with the right knee implant.No revision has been reported at this time.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay correct information and 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.This report is number 1 of 3 mdrs filed for the same patient (reference 1825034-2016-00978 / 02117 / 02118).

Event Description

It was reported that patient experienced buckling with quadriceps weakness in both knees approximately six (6) months post-implantation.

• Brand Name: OXF ANAT BRG LT SM SIZE 3 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterton industrial estate; bridgend
• 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: 5519275
• MDR Text Key: 40931632
• Report Number: 0001825034-2016-00978
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 159540
• Device Lot Number: 2518251
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2011
• 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): Required Intervention
• Patient Age: 56 YR