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

Model Number 579.0103

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 05/25/2022

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) initial report.Additional information, including operative notes, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls post primary surgery and an update on the patient post revision has been requested to progress with the investigation of the 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.

Event Description

Metafix collared / trinity revision of the stem and ceramic head after 6 days due to pain.

Manufacturer Narrative

Per (b)(4) final report.Additional information, including operative notes, whether the patient followed correct post-op protocol, whether the sciatic nerve injury may have occurred during primary surgery, whether the patient experienced any slips / falls post primary surgery and an update on the patient post revision was requested to progress with the investigation of the event.The reporter responded to state that it was thought the sciatic nerve inury was sustained during primary surgery and that post revision, the patient was doing well.The appropriate device details were 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 above, no further investigation can be conducted and the root cause of the pain could not be determined, however, it may be due to the sciatic nerve injury sustained during primary surgery.Therefore, this case is now considered closed.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.

Event Description

Metafix collared / trinity revision of the stem and ceramic head after 6 days due to pain.It was reported that sciatic nerve injury was observed during the revision.

• Brand Name: METAFIX COLLARED
• Type of Device: METAFIX HIP STEM (COLLARED)
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; 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: 14565105
• MDR Text Key: 293079648
• Report Number: 9614209-2022-00037
• Device Sequence Number: 1
• Product Code: KWY
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 579.0103
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 495603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: BIOLOX DELTA CERAMIC HEAD: 104.3605, 488340; BIOLOX DELTA CERAMIC HEAD: 104.3605, 488340; TRINITY CUP: 324.03.752, 486564; TRINITY CUP: 324.03.752, 486564; TRINITY ECIMA LINER: 322.03.636, 500736; TRINITY ECIMA LINER: 322.03.636, 500736; TRINITY SCREW: 321.025, 481047; TRINITY SCREW: 321.025, 481047; TRINITY SCREW: 321.025, 490504; TRINITY SCREW: 321.025, 490504; TRINITY SCREW: 321.035, 498190; TRINITY SCREW: 321.035, 498190
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female