MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA; OXFORD HXLPE BEARINGS

Catalog Number 159569

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/10/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Concomitant medical products - oxf uni tib tray sz c rm pma , item 154723, lot 1464608, therapy date - device remains implanted, item 154600, lot 1464608, therapy date - device remains implanted.Report source, foreign - event occurred in (b)(6).Device history record (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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01151 and 3002806535-2018-01152.

Event Description

Patient died and cause of death unknown.Implant was in place upon last contact.

• Brand Name: OXF ANAT BRG RT SM SIZE 4 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• 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: 7999683
• MDR Text Key: 124836965
• Report Number: 3002806535-2018-01153
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 159569
• Device Lot Number: 1443137
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2008
• 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 Age: 88 YR