MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN BIOLOX CERAMIC HEAD; UNKNOWN HIP ARTHROPLASTY

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial hip arthroplasty on an unknown date.Subsequently, a revision procedure was performed on an unknown date due to implant fracture.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Biomet uk ltd have attempted to contact the hospital 3 times, however, we have not been able to retrieve any further information relevant to this complaint.The product has not been returned to biomet for evaluation, therefore, a thorough investigation has not been possible.We have not been provided with x-rays or any supporting documentation which could provide additional information.The product and lot number identification necessary to review manufacturing history and the complaint history was not provided.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.

Event Description

It was reported that a patient underwent an initial hip athroplasty on an unknown date.Subsequently, a revision procedure was performed on an unknown date due to implant fracture.

• Brand Name: UNKNOWN BIOLOX CERAMIC HEAD
• Type of Device: UNKNOWN HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10957176
• MDR Text Key: 220129429
• Report Number: 3002806535-2020-00511
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention