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

Catalog Number 159568

Device Problem Material Erosion (1214)

Patient Problem Reaction (2414)

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: oxford cementless femur, catalog 154925, lot 3244323; oxford tibial tray, catalog 166573, lot 3226041.(b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00192 and 3002806535-2017-00194.

Event Description

It was reported that the patient underwent a revision of a right partial knee prosthesis approximately three years post implantation due to metallosis of the knee joint, wear, and possible abrasion of the femoral coating.The patient was converted to a total knee prosthesis.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Analysis of the retrieved implants and radiographs did not show any obvious source of material loss that may have contributed to the reported metallosis.The bearing surfaces look in relatively good condition with few signs of adverse wear.Review of ap radiograph reported the bearing shows possible evidence of posterior impingement, however the lateral radiograph does not show any signs of a posterior osteophyte or overhang that could be responsible for this.The source for this impingement is not clear with the evidence provided.The source of the observed anterior wear also cannot be determined.Therefore the evidence provided did not show a clear reason for the observed metallosis.Dhr was reviewed and no discrepancies were found.Root cause of the event was unable to be determined as the event was not confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF ANAT BRG RT SM SIZE 3 PMA
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6461606
• MDR Text Key: 71825892
• Report Number: 3002806535-2017-00193
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 159568
• Device Lot Number: 3113113
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• 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: 62 YR
• Patient Weight: 70