MAUDE Adverse Event Report: BIOMET UK LTD. EXCEED ABT E1 N/FLNG CUP 36X54; HIP PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products:medical product: delta ceramic fem hd 36/-3mm, catalog #: 650-0660, lot #: not reported.Report source, foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00267.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.Product not returned.

Event Description

The (b)(6) reported that a patient underwent an initial right hip arthroplasty.Subsequently, a revision procedure was performed due to unknown reason.Cup and head were revised.

• Brand Name: EXCEED ABT E1 N/FLNG CUP 36X54
• Type of Device: HIP PROSTHESIS
• 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: 8415642
• MDR Text Key: 138647979
• Report Number: 3002806535-2019-00268
• Device Sequence Number: 1
• Product Code: JDD
• 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: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: EP-113654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/13/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 83