MAUDE Adverse Event Report: . DELTA CER FEM HEAD 28/0MM T1; PROSTHESIS, HEAD

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problem No Information (3190)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

The 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 or deviation.Device availability - the device is reportedly available for evaluation; however, it has not been received by the legal manufacturer to date.In the event that the device is received and evaluated, a follow-up report will be sent to the fda to provide results.Return expected, not yet received.

Event Description

During a bipolar hip arthroplasty, the surgeon felt the ceramic head had restricted movement within the bipolar cup.The procedure was completed with an alternative bipolar cup and ceramic head; although, the surgeon was still not satisfied with the components' articulation.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Visual inspection of the product noted nothing out of the ordinary it measured within specification.Review of manufacture records show no deviations or anomalies during the manufacturing process.There is nothing that would indicate the product left biomet non-conforming.The event could have possibly been caused by third party debris or the head not being fully reduced in the liner, however, with the given information a definitive root cause cannot be determined.This report is number 1 of 4 mdrs filed for the same patient (reference 3002806535-2016-00221 / 3002806535-2016-00762 / 1825034-2016-03413 / 1825034-2016-03785).

• Brand Name: DELTA CER FEM HEAD 28/0MM T1
• Type of Device: PROSTHESIS, HEAD
• Manufacturer (Section D): .; 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: 5638212
• MDR Text Key: 44662818
• Report Number: 3002806535-2016-00221
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK051411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

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
• Device Catalogue Number: 650-1158
• Device Lot Number: 2015020328
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention