MAUDE Adverse Event Report: CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM

Model Number 321.02.348

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.The device details were provided and the relevant device manufacturing records will be identified and reviewed.The failure mode (incorrect lot code) on the patient stickers was confirmed based on a photograph provided by the reporter.Additional was requested to the reporter, such as the lot code marked on the device, the lot code on the part blister, and if the part was implanted.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

Trinity cluster shell - discrepancy between the lot codes on the inside and the outside labels.All other information on the labels is correct.

Event Description

Trinity cluster shell - discrepancy between the lot codes on the inside and the outside labels.All other information on the labels is correct.

Manufacturer Narrative

Per - 3682 follow-up report.The device details were provided and the relevant device manufacturing records were identified and reviewed.The label sample attached to the dhr shows the same lot code on inside and outside labelling.No extra label was printed.The printing history shows also no discrepancy between the inside and the outside labelling.The packaging was dismissed by the hospital and was therefore not available to be returned.The only remaining label is the patient sticker in the patient record.Other parts from the same batch were either implanted or sold, therefore they were not available to perform a sampling.Sampling was performed on other parts, and no discrepancy between inside and ouside labels was found.A photograph of the affected inside label was provided by the reporter, showing indeed an incorrect lot code ( i.E.Not matching the dhr), but the photograph was not very clear.Therefore a confirmation of the failure was requested: after consulting the patient record, it was reported that the lot code on the patient stickers was finally correct (i.E.The same as in the dhr).This means that the failure would not be confirmed.It was requested to provide a photograph of this patient sticker in order to have proof.Conlusions 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.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.

Manufacturer Narrative

Per - 3682 final report the device details were provided and the relevant device manufacturing records were identified and reviewed.The label sample attached to the dhr shows the same lot code on inside and outside labelling.No extra label was printed.The printing history shows also no discrepancy between the inside and the outside labelling.The packaging was dismissed by the hospital and was therefore not available to be returned.The only remaining label is the patient sticker in the patient record.Other parts from the same batch were either implanted or sold, therefore they were not available to perform a sampling.Sampling was performed on other parts, and no discrepancy between inside and outside labels was found.A photograph of the affected inside label was provided by the reporter, showing indeed an incorrect lot code ( i.E.Not matching the dhr), but the photograph was not very clear.Therefore a confirmation of the failure was requested: after consulting the patient record, it was reported that the lot code on the patient stickers was finally correct (i.E.The same as in the dhr).A clear photograph of this patient sticker was provided, and the lot code was indeed correct.Therefore the failure mode was not confirmed.This case is 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

Trinity cluster shell - discrepancy between the lot codes on the inside and the outside labels.All other information on the labels is correct.

• Brand Name: TRINITY ACETABULAR HIP SYSTEM
• Type of Device: TRINITY ACETABULAR HIP SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, gl7 1yj ; UK
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester, gl7 1yj ; UK
• Manufacturer Contact: marie-anne euzen ; the corinium center; cirencester, gl7 1yj ; UK
• MDR Report Key: 11659774
• MDR Text Key: 251695468
• Report Number: 9614209-2021-00045
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K093472
• 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,Followup
• Report Date: 01/12/2022

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: 321.02.348
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 427883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 04/01/2021; 04/01/2021
• Supplement Dates FDA Received: 07/24/2021; 01/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2019
• 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
• Patient Sex: Female