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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.Current information is insufficient to permit conclusions as to the cause of the events.Product identification was not provided for the patient mentioned in the journal article.The article was written by sok chuen tan, adrian c.K.Lau, christopher del balso, james i.Howard, brent a lanting, matthew g.Teeter.This information was originally reported on 3002806535-2016-00132 which referenced a journal article written on a study that this patient took part in.Product location unknown.

Event Description

Information was received based on review of a journal article titled, "tribocorrosion: ceramic and oxidized zirconium vs cobalt-chromium heads in total hip arthroplasty," which aimed to compare tribocorrosion between matched ceramic and cobalt-chromium femoral head trunnions, and between matched oxinium and cobalt-chromium (cocr) femoral head trunnions.Secondary objectives were to investigate if taper design, depth of trunnion, implantation time, age, body mass index and gender have an effect in fretting and corrosion.The study consisted of 1320 implants evaluated to ensure an exact match for taper design and head size, and best possible match for neck length and implantation.All prostheses were retrieved between 1999 and 2015.A patient was identified in the article that underwent a total hip arthroplasty on an unknown date.Patient follow-up results provided at 16.3 years post-implantation indicates patient underwent a revision procedure due to polyethylene wear.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN HIP
• 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: 5525899
• MDR Text Key: 41144259
• Report Number: 3002806535-2016-00142
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2016

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: UNKNOWN HIP
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/25/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR