MAUDE Adverse Event Report: CORIN LTD METAFIX; CORIN METAFIX HIP STEM

Model Number 579.2103

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Subluxation (4525); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  Injury  

Event Description

Trinity / metafix collared revision of the head and stem after approximately 2 years and 10 months due to subsidence of the stem.

Manufacturer Narrative

(b)(4) initial report.Additional information, including operative notes (primary and revision), patient activity level, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post 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.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 distributor caused or contributed to this event.

Manufacturer Narrative

(b)(4).Additional information, including operative notes (primary and revision), patient activity level, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post 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 could not be 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.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to this event.Based on the available information, no further investigation can be conducted and the root cause of the reported stem subsidence could not be determined.Therefore, 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 distributor caused or contributed to this event.

• Brand Name: METAFIX
• Type of Device: CORIN METAFIX HIP STEM
• 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: 18214903
• MDR Text Key: 329063103
• Report Number: 9614209-2023-00269
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153381
• 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: 02/05/2024

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: 579.2103
• Device Lot Number: 462154
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/10/2023
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/24/2020
• 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: 104.3605, 466500; TRINITY CUP: 321.03.352, 460590; TRINITY ECIMA LINER: 322.03.636, 464103
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male