MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN EXCEED CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/04/2017

Event Type  Injury  

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 & 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: 3002806535-2017-00587, 3002806535-2017-00588, 3002806535-2017-00589, 3002806535-2017-00590.

Event Description

It was reported one patient underwent a hip revision due to infection.No further information has been reported.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the 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.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 EXCEED CUP
• 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: 6714811
• MDR Text Key: 80073315
• Report Number: 3002806535-2017-00588
• Device Sequence Number: 1
• Product Code: JDD
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PNI
• 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: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/14/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: No
• 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 FEMORAL HEAD; UNKNOWN LINER
• Patient Outcome(s): Hospitalization; Required Intervention