MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING LARGE SIZE 3MM THICK RIGHT; PROSTHESIS, KNEE

Catalog Number 159582

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: oxford partial knee system twin pegged cementless femur v6 large 161475 lot 2454578; oxford partial knee systemsize d with slots hydrozyapatite coated right medial tibial tray medial catalog us166577 lot r3050483a.The components remain implanted in the patient.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00240 and 3002806535-2017-00242.

Event Description

It has been reported that a patient enrolled in a clinical study experienced a clicking and pain in the medial right knee as well as clunking upon walking and pain in the suprapatellar pouch approximately two years post partial knee arthroplasty.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed by review of x-rays provided.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.

Event Description

It has been reported that a patient enrolled in a clinical study experienced a clicking and pain in the medial right knee as well as clunking upon walking and pain in the suprapatellar pouch approximately two years post partial knee arthroplasty.Subsequently, a revision procedure was performed.

• Brand Name: OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING LARGE SIZE 3MM THICK RIGHT
• 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: 6512999
• MDR Text Key: 73448536
• Report Number: 3002806535-2017-00241
• 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: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/12/2020
• Device Catalogue Number: 159582
• Device Lot Number: 170910
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: 11/24/2017
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2015
• 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; Disability
• Patient Age: 62 YR
• Patient Weight: 122