MAUDE Adverse Event Report: CORIN LTD TRINITY; BIOLOX DELTA CERAMIC HEAD

Model Number 104.3615

Device Problems Labelling, Instructions for Use or Training Problem (1318); Manufacturing, Packaging or Shipping Problem (2975); Wrong Label (4073)

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

Event Date 12/22/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report: the issue was identified intra-op and not implanted thus there was no reported patient impact.Nevertheless, the surgery time was extended more than 30 minutes.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.Details will be provided in a supplemental report upon completion of the investigation.The submission of this report does not constitute an admission that the device, reporting entity, entities representative, or distributor caused or contributed to this event.

Event Description

Trinity/ceramic head: an implant box contained a "32+8 ceramic head" while it was marked "36+8 ceramic head".

Manufacturer Narrative

(b)(4) - final report.The issue was identified intra-op and not implanted, thus there was no reported patient impact.Nevertheless, the surgery time was extended more than 30 minutes.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.It was identified that there was a mix-up of two batches and that incorrect labels were applied.Corin has initiated an internal investigation to implement corrective / preventative actions and a recall was completed to retrieve all non-implanted devices from the 2 batches.Therefore, this case is now considered closed.The submission of this report does not constitute 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 32xl was labelled and packed as a 36xl head.

• Brand Name: TRINITY
• Type of Device: BIOLOX DELTA CERAMIC HEAD
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 16049686
• MDR Text Key: 308538646
• Report Number: 9614209-2022-00146
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

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: 104.3615
• Device Catalogue Number: N/A
• Device Lot Number: 503151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Distributor Facility Aware Date: 12/23/2022
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2022
• 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