MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA MED SZ 4

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 10/19/2017

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: item: oxf uni tib tray sz d rm pm, catalog #154725, item: oxford pks femoral cocr medium, catalog # 154601.As no lot number was provided, the device history records could not be reviewed.The manufacturer did not receive the device for investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.The hospital has informed us that there is no further information and therefore the investigation is completed based on current available information.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient died and cause of death unknown.To the best of the site¿s knowledge the implants remained in situ at the time of death.There is no indication that biomet products caused patient's death.The hospital has informed us that there is no further information.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 PMA MED SZ 4
• Type of Device: OXF ANAT BRG RT MD SIZE 4 PMA MED SZ 4
• 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: 7258649
• MDR Text Key: 99526415
• Report Number: 3002806535-2018-00244
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• 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: 78 YR
• Patient Weight: 59