MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD TIBIA TRAY; PROSTHESIS, HIP

Model Number N/A

Device Problem Unstable (1667)

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

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Multiple mdr reports were filed for this event.Please see reports: 3002806535-2018-01048, 3002806535-2018-01049, 3002806535-2018-01050.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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 was reported in clinical study 444 the patient had severe to extreme pain, feeling knee might suddenly give away "most of the time", moderate difficulty performing daily activities, constant limping requiring cane as a walking aid six months post primary implantation.Attempts have been made and no further information has been provided.

• Brand Name: UNK OXFORD TIBIA TRAY
• Type of Device: PROSTHESIS, HIP
• 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: 7864292
• MDR Text Key: 119820886
• Report Number: 3002806535-2018-01049
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK OXFORD BEARING, PN UNKNOWN LN UNKNOWN; UNK OXFORD CEMENTLESS FEM, PN UNKNOWN LN UNKNOWN
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 53