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

Model Number 104.3600

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

Patient Problem Physical Asymmetry (4573)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4) - initial report.Additional information, including operative notes of the revision have been requested in order to progress with the investigation of this event, and will be provided in a supplemental report upon completion of the investigation.The surgeon has stated that they had trouble adjusting the stem and that this was not linked to the device performance or design.It was due to patient anatomy/weight.The appropriate devices details were provided and the relevant device manufacturing records will be identified and reviewed.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 occured outside of the usa.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

Meije duo / trinity revision of the stem, biolox delta ceramic head and liner after approximately 1 year and 2 months due to leg length discrepancy.Please note: the reported meije duo stem is not cleared for sale or distribution in the usa and this event occurred outside of the usa.

Event Description

Meije duo / trinity revision of the stem, biolox delta ceramic head and liner after approximately 1 year and 2 months due to leg length discrepancy.Please note: the reported meije duo stem is not cleared for sale or distribution in the usa and this event occurred outside of the usa.

Manufacturer Narrative

(b)(4) - final report.Additional information requested was provided.The appropriate devices details have been provided and the relevant device manufacturing records have been identified and reviewed.The devices were manufactured according to specifications at the time of manufacture.The surgeon has stated that they had trouble adjusting the stem and that this was not linked to the device performance or design.It was due to patient anatomy/weight.Based on the above, no further investigation can be conducted.As the surgeon confirmed that the link between the devices and the event is excluded, the root cause is considered as external.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 occured outside of the usa.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: 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: 18988210
• MDR Text Key: 338729447
• Report Number: 9614209-2024-00307
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

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: 104.3600
• Device Catalogue Number: N/A
• Device Lot Number: 511874
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2022
• 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: MEIJE DUO / STEM: MODEL HLP411 LOT 495360; MEIJE DUO / STEM: MODEL HLP411 LOT 495360; TRINITY / INSERT: MODEL UNKNOWN LOT UNKNOWN; TRINITY / INSERT: MODEL UNKNOWN LOT UNKNOWN
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female