MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT X-SM SZ 4 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Fall (1848); Muscle Weakness (1967); Pain (1994)

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 5 states, "temporary or permanent nerve damage may result in pain and numbness." number 20 states, "persistent pain." the following sections could not be completed with the limited information provided.Date implanted - unknown.Date explanted - remains implanted.

Event Description

It was reported that patient underwent a left partial knee arthroplasty on an unknown date.Subsequently, patient reported experiencing weakness and balance issues, weakness in the quadriceps, and severe saphenous neuralgia five months post-op.The patient further reported a fall around the beginning of (b)(6) 2016.A revision procedure has not been indicated at this time.

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 a left partial knee arthroplasty on (b)(6) 2012.Subsequently, patient reported experiencing weakness and balance issues, weakness in the quadriceps, and severe saphenous neuralgia five months post-op.The patient further reported a fall around the beginning of (b)(6) 2016.A revision procedure has not been indicated at this time.

• Brand Name: OXF ANAT BRG LT X-SM SZ 4 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estate; brigend
• 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: 5516289
• MDR Text Key: 40869365
• Report Number: 0001825034-2016-00967
• 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
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 159791
• Device Lot Number: 2491601
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2011
• 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): Other
• Patient Age: 86 YR