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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 08/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted late as it has been identified in remediation.Reported event was unable to be confirmed due to limited information received from the customer.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.Not returned to manufacturer.

Event Description

It was reported in clinical study 453 the patient had severe pain, difficulty ambulating, loss of range of motion, and difficulty sleeping post-operatively.Attempts have been made and no further information has been made available at this time.

• Brand Name: OXF UNI TIB TRAY SZ C LM 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: 7412352
• MDR Text Key: 104876321
• Report Number: 3002806535-2018-00692
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 154722
• Device Lot Number: 712670
• Other Device ID Number: (01) 05019279388882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2014
• 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
• Treatment: 159548 OXF ANAT BRG LT MD LOT 805720; 161469 OXF TWIN-PEG CMNTD FEM LOT 534550
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 74