MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN FEMORAL HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/04/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Date of event ¿ date published.Report source, foreign ¿ event occurred in (b)(6).P.P.Salo, p.B.Honkanen, i.Ivanova, a.Reito, j.Pajamäki, a.Eskelinen (2017).High prevalence of noise following delta ceramic-on-ceramic total hip arthroplasty.The bone and joint journal, 99-b, 44-50.Doi: 10.1302/0301-620x.99b1.37612.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00583, 3002806535-2017-00584, 3002806535-2017-00586.

Event Description

It was reported 8 patients who underwent a total hip arthroplasty expired during a study.Patient deaths relation to procedure is unknown.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from customer.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.There is no indication in the journal that the death is related to the device implanted.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: UNKNOWN FEMORAL HEAD
• 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: 6714802
• MDR Text Key: 80072644
• Report Number: 3002806535-2017-00585
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• 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
• Treatment: UNKNOWN BIMETRIC STEM; UNKNOWN EXCEED CUP; UNKNOWN LINER
• Patient Outcome(s): Death