MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN PEG CMNTLS FMRL SM; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Cyst(s) (1800)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: oxf anat brg lt sm size 3 pma sml sz 3, catalog #: 159540, lot #: 319510; medical product: oxford cementless tibia a lm, catalog #: us166845, lot #:r3050449a.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00362, 3002806535-2019-00363.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that a patient underwent an initial left knee replacement procedure.Subsequently, the patient suffered a cyst in the lateral femoral condyle / pigmented villonodular synovialitis and as a result a two stage revision procedure was carried out.

Event Description

It was reported that a patient underwent an initial left knee replacement procedure.Subsequently, the patient suffered a cyst in the lateral femoral condyle / pigmented villondular synovisits and as a result a two stage revision procedure was carried out.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of x-rays provided.From the ml radiograph it is possible that there is some third-body debris present posteriorly in the joint space, and there is also a slight gap evident between the tibial tray and the tibial plateau.This gap appears to remain constant in the radiographs taken at the future time points.Surgical notes or patient-related information such as height, weight and activity level have not been provided.Pigmented villonodular synovitis (pvns) is a rare, benign proliferation of the synovium.Houdek et al.State ¿patients with a history of pvns should be cautioned when undergoing arthroplasty on the elevated risk of.Subsequent procedures.¿ it is not clear whether this patient had a history of pvns however there is nothing to suggest that the reason for revision was related to the function of the device in this instance.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 TWIN PEG CMNTLS FMRL SM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8494765
• MDR Text Key: 141306569
• Report Number: 3002806535-2019-00361
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 161473
• Device Lot Number: R2409854A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 86