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

Model Number 579.2103

Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During a surgery it was identified that a metafix collared size 4 stem (579.2104, 416669) was incorrectly labeled as a metafix collared size 3 stem (579.2103, 416667).Another metafix collared size 3 stem (579.2103, 390002) was located and implanted with no reported issues.The two affected batches (pn: 579.2104, lc:416669 and pn: 579.2103, lc:416667) were batches of 10.The location of all parts from these two batches have been identified and the unused stems are being returned to corin.Three of the metafix collared size 3 stem had been sent to the usa and were located in the corin usa warehouse, they had not been sent to any hospitals, these have been returned to corin uk.No other affected parts from the two batches were in the usa.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

During a surgery it was identified that a metafix collared size 4 stem (579.2104, 416669) was incorrectly labeled as a metafix collared size 3 stem (579.2103, 416667).Another metafix collared size 3 stem (579.2103, 390002) was located and implanted with no reported issues.

Event Description

During surgery it was identified that a metafix collared size 4 stem (579.2104, 416669) was incorrectly labeled as a metafix collared size 3 stem (579.2103, 416667).Another metafix collared size 3 stem (579.2103, 390002) was located and implanted with no reported issues.

Manufacturer Narrative

Per -2265 final report.During surgery it was identified that a metafix collared size 4 stem (579.2104, 416669) was incorrectly labeled as a metafix collared size 3 stem (579.2103, 416667).Another metafix collared size 3 stem (579.2103, 390002) was located and implanted with no reported issues.The two affected batched (pn: 579.2104, lc: 416669 and pn: 579.2103, lc: 416667) were batches of 10.The location of all parts from these two batches have been identified and the unused stems have been returned to corin.Three of the metafix collared size 3 stem had been sent to the usa and were located in the corin usa warehouse, they had not been sent to any hospitals, these have been returned to corin uk.No other affected parts from these two batches were in the usa.The investigation of this event identified that the reported event occurred due to human error whereby the process was incorrectly followed.Since the manufacture of this device, corin has introduced improvements to the process and review activities which would capture any such issues.Therefore this case is now considered closed.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

Bi-polar revision after approximately 4 months as the head dissasembled from the liner.

Manufacturer Narrative

Per -571 final report.It was unknown when submitting the initial report for this file whether a device revision had occurred.It has since been confirmed that the patient required a revision due to the head dissengaging from the liner.Post primary and pre revision x-rays and operative notes were requested but have not been provided for this investigation.The device manufacturing records have been identified and reviewed and the explanted device was returned for examination where it was measured.It was confirmed that the device conformed to material and dimensional specification.Based on this, and due to the lack of information provided, it has not been possible to determine the root cause of this event and thus corin now consider this case closed.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: 8858271
• MDR Text Key: 153718951
• Report Number: 9614209-2019-00073
• Device Sequence Number: 1
• Product Code: LZO
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2019

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 Expiration Date: 03/26/2024
• Device Model Number: 579.2103
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 416667
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 08/03/2019
• Supplement Dates Manufacturer Received: 10/12/2017; 07/04/2019
• Supplement Dates FDA Received: 09/30/2019; 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: METAFIX STEM - 579.2103, 390002; METAFIX STEM - 579.2103, 390002; METAFIX STEM - 579.2104, 416669; METAFIX STEM - 579.2104, 416669
• Patient Outcome(s): Hospitalization; Other; Required Intervention