MAUDE Adverse Event Report: BIOMET UK LTD. 28MM BIOLOX DELTA MODULAR CERAMIC HEAD TYPE I TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

The necessary manufacturing history was not provided for review.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Expiration date - ni.Manufacture date ¿ ni.This report is number 2 of 4 mdrs filed for the same patient (reference 3002806535-2016-00221 / 3002806535-2016-00762 / 1825034-2016-03413 / 1825034-2016-03785).

Event Description

During a bipolar hip arthroplasty, on the second attempted modular head used, the surgeon felt the ceramic head had restricted movement within the bipolar cup but implanted the components.

• Brand Name: 28MM BIOLOX DELTA MODULAR CERAMIC HEAD TYPE I TAPER
• 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: 5975141
• MDR Text Key: 55567770
• Report Number: 3002806535-2016-00762
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK131684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 650-1158
• Device Lot Number: 2015030291
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2016
• 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