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

Model Number 104.3605

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient activity level, patient medical history and an update on the patient following the revision have been requested.It was reported that this revision was the second revision for infection of the patient.The biolox delta modular head was implanted during the first patient revision.No additional data was available.The device cannot be returned, therefore the analysis is limited.The appropriate device details were provided and the relevant device manufacturing records have been identified.Conclusion of their review 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

Biolox delta modular head revision after approximately 2 weeks due to infection.

Manufacturer Narrative

Per -3378 final report.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records were manufactured, cleaned, packaged and sterilised in accordance with the correct specifications at the time of manufacture.Investigation was requested to the supplier of the biolox ceramic head: it concluded that the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of a pre-existing material defect.Due to the fact the ceramic head was not returned, no further investigation could be performed.The sterilisation method and sterile barrier system used to package trinity devices has a long history of safe and effective use at corin and has been validated in accordance with the relevant standards.Based on the available information no further investigation can be conducted.Infection is a known complication with any invasive surgery and thus this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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.

Event Description

Biolox delta modular head revision after approximately 2 weeks due to infection.

• Brand Name: BIOLOX DELTA CERAMIC HEAD
• Type of Device: BIOLOX DELTA MODULAR HEAD
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, gl7 1yj ; UK
• MDR Report Key: 11001855
• MDR Text Key: 221238517
• Report Number: 9614209-2020-00126
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K111481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 104.3605
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 462591
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL CUP , DEVICE DETAILS ARE UNKNOWN; GLOBAL CUP , DEVICE DETAILS ARE UNKNOWN; GLOBAL LINER, PART DETAILS ARE UNKNOWN; GLOBAL LINER, PART DETAILS ARE UNKNOWN; PARAGON STEM, DEVICE DETAILS ARE UNKNOWN; PARAGON STEM, DEVICE DETAILS ARE UNKNOWN; GLOBAL CUP , DEVICE DETAILS ARE UNKNOWN; GLOBAL LINER, PART DETAILS ARE UNKNOWN; PARAGON STEM, DEVICE DETAILS ARE UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR