MAUDE Adverse Event Report: BIOMET UK LTD. OXF PKS ANAT MEN BRG UHMWPE RT MED SZ 3; PROSTHESIS, KNEE

Model Number N/A

Device Problem Scratched Material (3020)

Patient Problems Pain (1994); Swelling (2091)

Event Date 06/03/2016

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.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 20 states, "persistent pain." requested but not yet returned.

Event Description

Patient was revised on the right side approximately fifteen months post-implantation due to pain, swelling and effusion.During the revision procedure, it was noted the polyethylene bearing showed evidence of abrasions.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Examination of returned device found no evidence of product non-conformance.A visual assessment of the component highlights a severe amount of pitting and scratching on the superior articulating surface, which can likely be attributed to contact and articulation with the ¿pointed bone fragments¿ that were evident within the joint space.The surgical notes state that these fragments ¿can certainly be responsible for the pain in the knee.¿ a conclusive root cause of the event could not be determined with the information provided.

• Brand Name: OXF PKS ANAT MEN BRG UHMWPE RT MED SZ 3
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: daniel tilbury ; waterton industrial estates; bridgend ; 0441656655
• MDR Report Key: 5799996
• MDR Text Key: 49743126
• Report Number: 3002806535-2016-00556
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 159575
• Device Lot Number: 3475696
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2014
• 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: 51 YR