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

Model Number 104.3605

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4).The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.The device was manufactured to the correct specifications at the time of manufacture.Potential root causes are currently being investigated and if determined, will be provided in a supplemental report upon completion of the investigation.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.

Manufacturer Narrative

Per -(b)(4) final report the device was not returned, therefore the failure mode could not be confirmed.Another part from the same batch was examined by corin, and it was found that the usage stickers and the ifu were provided.No other similar complaint was received from this batch, therefore this is considered to be an isolated event in this batch, due to human error.As this event was already reported in the past, corin had initiated a capa project to identify a root cause and implement any necessary corrective / preventative actions.This project was closed with a modification to the process to capture such errors.In addition, a sensitization of the packaging personnel was performed.This case is now considered 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.The submission of this report does not constitue an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

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 center; cirencester; cirencester, gl7 1yj GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 9848909
• MDR Text Key: 187242747
• Report Number: 9614209-2020-00027
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K103120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

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: 104.3605
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 442989
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1