MAUDE Adverse Event Report: BIOMET UK LTD. EXCEED ABT RINGLOC-X SHELL PC DIA50MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Entrapment of Device (1212); Malposition of Device (2616); Positioning Problem (3009)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in (b)(6) manufactures a similar device in the united states under 510k number (b)(4).

Event Description

It was reported that patient underwent a right total hip arthroplasty on (b)(6) 2015.Subsequently, a revision procedure was performed on (b)(6) 2015 due to impingement.The acetabular cup was removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to correct and relay additional information.This report is number 1 of 3 mdr's filed for the same patient (reference 3002806535-2016-00025, 00385, 00386).Product location unknown.

Event Description

It was reported that a patient enrolled in a clinical study underwent a revision approximately 9 months post-implantation due to impingement.During the procedure, the acetabular cup was removed and replaced.

• Brand Name: EXCEED ABT RINGLOC-X SHELL PC DIA50MM
• 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: daniel tilbury ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 5364293
• MDR Text Key: 35812984
• Report Number: 3002806535-2016-00025
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 131350
• Device Lot Number: 3405666
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 85