MAUDE Adverse Event Report: CORIN MEDICAL BIOLOX; BIOLOX DELTA CERAMIC HEAD

Model Number 104.3600

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4) combined report.Surgery was not delayed, there was no impact to the patient and the device was implanted with no reported issues.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.This device was manufactured and packed in sep 2019 as part as a batch of (b)(4).No other reports have been received in relation to this batch.Two parts were identified in corin stock and were opened, it was found that all relevant implant usage labels and the ifu was present and thus this case is considered isolated and will now be closed.Please note: this report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.

Event Description

Trinity biolox delta ceramic head was received and there was no ifu or implant usage labels in the product carton.

• Brand Name: BIOLOX
• Type of Device: BIOLOX DELTA CERAMIC HEAD
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester; gloucestershire, GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester; gloucestershire, GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: franck didier ; the corinium centre; cirencester; gloucestershire, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 9675808
• MDR Text Key: 190903208
• Report Number: 9614209-2020-00008
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K103120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 104.3600
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 441613
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1