MAUDE Adverse Event Report: CORIN MEDICAL METAFIX; HIP STEM (COLLARED)

Model Number 579.0104

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information, including post primary and pre revision x-rays, operative notes, patient age, patient activity level, patient medical history, whether the patient experienced any trauma and an update on the patient post revision has been requested in order to progress with the investigation, 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.

Event Description

Trinity dual mobility / metafix collared revision of the ecima insert, modular head and stem after 18 days due to a periprosthetic fracture.

Event Description

Trinity dual mobility / metafix collared revision of the ecima insert, modular head and stem after 18 days due to a periprosthetic fracture.

Manufacturer Narrative

(b)(4).Final report.Additional information, including post primary and pre revision x-rays, operative notes, patient age, patient activity level, patient medical history, whether the patient experienced any trauma and an update on the patient post revision was requested in order to progress with the investigation, however, this information has not been provided and thus the scope of the investigation was limited.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause of the reported peri-prosthetic fracture has not been identified.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: HIP STEM (COLLARED)
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 11472805
• MDR Text Key: 239405159
• Report Number: 9614209-2021-00033
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K153381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 579.0104
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 443677
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP - 321.04.354, 464082; TRINITY CUP - 321.04.354, 464082; TRINITY DM COCR LINER - 321.04.540, 450320; TRINITY DM COCR LINER - 321.04.540, 450320; TRINITY DM ECIMA INSERT - 325.04.042, 441746; TRINITY DM ECIMA INSERT - 325.04.042, 441746; TRINITY MODULAR HEAD - E321.028, 429331; TRINITY MODULAR HEAD - E321.028, 429331; TRINITY CUP - 321.04.354, 464082; TRINITY DM COCR LINER - 321.04.540, 450320; TRINITY DM ECIMA INSERT - 325.04.042, 441746; TRINITY MODULAR HEAD - E321.028, 429331
• Patient Outcome(s): Hospitalization; Required Intervention