MAUDE Adverse Event Report: CORIN MEDICAL CORIN METAFIX HIP STEM; METAFIX COLLARED SIZE 3 STANDARD

Model Number 579.0103

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4) initial report, the inaccurate labeled device was identified during surgery.The surgery was delayed of 20 min with no patient impact.The appropriate device details have been provided.The relevant device manufacturing records will be identified and will be reviewed.The return of the affected device has been requested.It is confirmed based on photograph that the part was packaged with the incorrect labeling.Conclusions 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

Metafix stem: implant packaging for a size 3 collared metafix stem contains a size 7 non collared metafix stem.This event caused a surgical delay of 20 mins.

Event Description

Metafix stem: implant packaging for a size 3 collared metafix stem contains a size 7 non collared metafix stem.This event caused a surgical delay of 20 mins.

Manufacturer Narrative

Per -4509 final report.The inaccurate labeled device was identified during surgery.The surgery was delayed of 20 min with no patient impact.It is confirmed based on photograph that the part was packaged with the incorrect labeling.The appropriate device details were provided, and the relevant device manufacturing records have been identified and reviewed.It was found that these two batches were manufactured in nov 2021 as part of a batch of 10 and 16 and were considered as packaged and labelled according to specification at the time of manufacture.Some sampling was performed on parts from these 2 batches and this failure seems to be isolated and does not impact the whole batches.A project is ongoing in order to investigate the rootcause and implement corrective actions.We trust that the actions which will be identified by the project team will negate a repeat of the reported failure mode.A field action is also on-going to retrieve the parts from both affected batches.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 distrubutor caused or contributed to this event.

• Brand Name: CORIN METAFIX HIP STEM
• Type of Device: METAFIX COLLARED SIZE 3 STANDARD
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YL; UK GL7 1YL
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester, gl7 1yj ; UK
• Manufacturer Contact: marie-anne euzen ; the corinium center; cirencester, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 13585289
• MDR Text Key: 288985964
• Report Number: 9614209-2022-00014
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 579.0103
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 485630
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2021
• 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: METAFIX STEM SIZE 7 579.1007 LOT 478179.; METAFIX STEM SIZE 7 579.1007 LOT 478179.