MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Ambulation Difficulties (2544)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product(s): a 161470, oxf twin-peg cmntd fem lg pma, 317380; 159583, oxf anat brg rt lg size 4 pma, 087060.Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the report event was not reported.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2018 - 00531, 3002806535 - 2018 - 00532.

Event Description

It was reported that a patient underwent right knee surgery.Subsequently, post-operative pain and other experiences were reported at the follow-up visits: some problems walking, unable to perform usual activities, pain in bed most nights, difficulty performing usual work, moderate difficulty going down stairs, limping, and moderate difficulty kneeling.At the 1-year follow-up, the complication, assistive device effect: patella tendonitis, was reported.At this time there is no indication of surgical delays or medical intervention.

• Brand Name: OXF UNI TIB TRAY SZ D
• 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: 7358784
• MDR Text Key: 103135659
• Report Number: 3002806535-2018-00530
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 154725
• Device Lot Number: 317560
• Other Device ID Number: (01) 05019279388912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2014
• 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): Other
• Patient Age: 49 YR
• Patient Weight: 83