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

Model Number 104.2805

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision), whether the implant chosen at primary surgery too small or too big, how it was identified that the incorrect size had been implanted, whether the patient had presented with any complications post primary, information on the size of implant used in the revision, whether any other corin devices implanted at primary surgery and an update on the patient post revision has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.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 revision after approximately 4 months.Reported to be due to the incorrect size implant being selected at primary.

Manufacturer Narrative

(b)(4) final report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision), whether the implant chosen at primary surgery too small or too big, how it was identified that the incorrect size had been implanted, whether the patient had presented with any complications post primary, information on the size of implant used in the revision, whether any other corin devices implanted at primary surgery and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information has not been provided and thus the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.There has not been a malfunction of a corin device, the incorrect size of implant was chosen by the surgeon at primary surgery and thus 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.

• Brand Name: BIOLOX DELTA
• 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: 16853953
• MDR Text Key: 314386602
• Report Number: 9614209-2023-00185
• 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
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 104.2805
• Device Lot Number: 488190
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/19/2023
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male