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

Model Number 104.3615

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

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4) initial report.The issue was identified intra-op and not implanted, thus there was no reported patient impact.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, entity's representative or distributor caused or contributed to this event.

Event Description

Trinity biolox delta ceramic heads: 2 32 extra-long heads were labelled as a size 36 extra-long.The issue was identified intra-operatively prior to use and the devices were not implanted.

Event Description

Trinity biolox delta ceramic heads: 2 32 extra-long heads were labelled as a size 36 extra-long.The issue was identified intra-operatively prior to use and the devices were not implanted.

Manufacturer Narrative

Per 5135 final report photos of the affected implants were provided and confirmed the failure mode.It was concluded that a mix-up had occurred between the 2 whole batches (part 104.3215 lot 503150 and part 104.3615 lot 503151).The relevant device manufacturing records have been identified and reviewed.These parts were initially manufactured as batch 464664 and 464665 and were reworked.Incorrect labels were applied during the rework.An internal project was raised in order to investigate this failure mode and implement corrective actions.A recall was also raised in order to retrieve all the non-implanted parts from the 2 batches.The return of the part from per 5182 will be handled as part of the recall.Thus, this case is now considered closed.Note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to the event.

• Brand Name: TRINITY BIOLOX DELTA
• Type of Device: BIOLOX DELTA CERAMIC HEAD
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester GL7 1 YJ,; UK GL7 1YJ,
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester GL7 1 YJ,; UK GL7 1YJ,
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 15758632
• MDR Text Key: 307561088
• Report Number: 9614209-2022-00122
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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
• Treatment: BIOLOX DELTA CERAMIC HEAD 104.3215 LOT 503150