MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D RM PMA

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 05/01/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Medical product - oxford uni femoral md, item 154601.Medical product - oxf anat brg rt md size 4 pma med sz 4, item 161468.Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-00850 and 3002806535-2018-00852.

Event Description

It was reported that a patient who was part of a clinical study died.To the best of the site¿s knowledge the implants remained in situ at the time of death.The cause of patient¿s death is unknown.If the site knew that the patient's death was device-related, this would be indicated in the adverse event form.

Manufacturer Narrative

(b)(4).The follow up report is being submitted to relay additional information.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided but it is not device related.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 UNI TIB TRAY SZ D RM PMA
• 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: 7534402
• MDR Text Key: 108925652
• Report Number: 3002806535-2018-00851
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• 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: 154725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Weight: 80