MAUDE Adverse Event Report: CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM; TRINITY WITH XL HEADS

Model Number 104.3215

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.The inaccurate labeled device was identified during surgery.The surgery was delayed of 30 min with no patient impact.The appropriate device details have been provided.The relevant device manufacturing records were identified and will be reviewed.It is confirmed based on photograph that the part was packaged with the incorrect labeling.Conclusions will be provided in a supplemental report.Please note: this report is filed with the fda due to an adverse 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

A trinity biolox delta ceramic head 36xl was found in a package labelled as 32xl head.

Event Description

A trinity biolox delta ceramic head 36xl was found in a package labelled as 32xl head.

Manufacturer Narrative

Per -3487 final report the inaccurately labeled device was identified during surgery.The surgery was delayed approximately 30 minutes and there was no patient impact.The appropriate device details have been provided.The relevant device manufacturing records have been identified and reviewed.A discrepancy was identified in relation to the size of the device, however, this discrepancy was not identified at the time of manufacture.It has been concluded that the labelling discrepancy was due to human error.Corin has initiated a project to implement corrective / preventative actions and provide training.A product recall is also being conducted.Therefore, this case is now considered closed.Please note: this report is filed with the fda due to an adverse 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 constitute an admission that the device, reporting entity, entity's representative or distrubutor caused or contributed to this event.

• Brand Name: TRINITY ACETABULAR HIP SYSTEM
• Type of Device: TRINITY WITH XL HEADS
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 11265778
• MDR Text Key: 229899056
• Report Number: 9614209-2021-00019
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K130343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 104.3215
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 464664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 01/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOLOX DELTA CERAMIC HEAD: 104.3615, 464665